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    <tradeName>Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD24130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:12.602Z</lastUpdated>
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    <udiDi>00845225003180</udiDi>
    <basicUdiDi>B-00845225003180</basicUdiDi>
    <tradeName>Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
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    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:10.200Z</lastUpdated>
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    <udiDi>00845225003173</udiDi>
    <basicUdiDi>B-00845225003173</basicUdiDi>
    <tradeName>Phoenix 1.5mm x 149cm 4F Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
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    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P15149K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:08.609Z</lastUpdated>
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    <udiDi>00845225003166</udiDi>
    <basicUdiDi>B-00845225003166</basicUdiDi>
    <tradeName>Phoenix 1.5mm x 149cm 4F Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P15149</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:07.802Z</lastUpdated>
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    <udiDi>00845225002992</udiDi>
    <basicUdiDi>B-00845225002992</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD22130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:20:01.395Z</lastUpdated>
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    <udiDi>00845225002985</udiDi>
    <basicUdiDi>B-00845225002985</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD22130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:59.795Z</lastUpdated>
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    <udiDi>00845225002978</udiDi>
    <basicUdiDi>B-00845225002978</basicUdiDi>
    <tradeName>Phoenix 2.4mm x 130cm 7F Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P24130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:57.392Z</lastUpdated>
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    <udiDi>00845225002961</udiDi>
    <basicUdiDi>B-00845225002961</basicUdiDi>
    <tradeName>Phoenix 2.4mm x 130cm 7F Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P24130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:55.796Z</lastUpdated>
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    <udiDi>00845225002725</udiDi>
    <basicUdiDi>B-00845225002725</basicUdiDi>
    <tradeName>Phoenix 1.8mm x 149cm 5F Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P18149K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:43.780Z</lastUpdated>
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    <udiDi>00845225002763</udiDi>
    <basicUdiDi>B-00845225002763</basicUdiDi>
    <tradeName>Phoenix Floppy Tip, Light Support Guidewire</tradeName>
    <deviceName>Phoenix Guidewire</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020202</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG14300LF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:42.177Z</lastUpdated>
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    <udiDi>00845225002732</udiDi>
    <basicUdiDi>B-00845225002732</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 149cm 6F Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P22149K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:41.378Z</lastUpdated>
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    <udiDi>00845225002718</udiDi>
    <basicUdiDi>B-00845225002718</basicUdiDi>
    <tradeName>Phoenix 2.4mm 7F Deflecting Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD24127K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:39.873Z</lastUpdated>
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    <udiDi>00845225002701</udiDi>
    <basicUdiDi>B-00845225002701</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 130cm 6F Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P22130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:23.722Z</lastUpdated>
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    <udiDi>00845225002695</udiDi>
    <basicUdiDi>B-00845225002695</basicUdiDi>
    <tradeName>Phoenix 1.8mm x 130cm 5F Atherectomy System</tradeName>
    <deviceName>Phoenix Atherectomy System</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P18130K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:23.016Z</lastUpdated>
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    <udiDi>00845225002657</udiDi>
    <basicUdiDi>B-00845225002657</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 149cm 6F Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P22149</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:21.310Z</lastUpdated>
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    <udiDi>00845225002640</udiDi>
    <basicUdiDi>B-00845225002640</basicUdiDi>
    <tradeName>Phoenix 1.8mm x 149cm 5F Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P18149</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:17.317Z</lastUpdated>
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    <udiDi>00845225002633</udiDi>
    <basicUdiDi>B-00845225002633</basicUdiDi>
    <tradeName>Phoenix 2.4mm 7F Deflecting Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD24127</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:16.522Z</lastUpdated>
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    <udiDi>00845225002626</udiDi>
    <basicUdiDi>B-00845225002626</basicUdiDi>
    <tradeName>Phoenix 2.2mm x 130cm 6F Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P22130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:15.716Z</lastUpdated>
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    <udiDi>00845225002619</udiDi>
    <basicUdiDi>B-00845225002619</basicUdiDi>
    <tradeName>Phoenix 1.8mm x 130cm 5F Atherectomy Catheter</tradeName>
    <deviceName>Phoenix Catheter</deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020602</emdnCode>
    <emdnDescription>PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P18130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T05:19:12.510Z</lastUpdated>
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    <udiDi>10845225002760</udiDi>
    <basicUdiDi>B-10845225002760</basicUdiDi>
    <tradeName>Phoenix Floppy Tip, Light Support Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Volcano AtheroMed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006912</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG14300LF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:51:35.435Z</lastUpdated>
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