FDA 510(k) Premarket Notification K171251: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter

Submission Details & Decision

Normalized public record details for 510(k) notification K171251.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K171251

Applicant / Sponsor

Creagh Medical

Device Name

014 Hydrophilic Coated PTA Balloon Dilatation Catheter

Product Code

LIT

Decision Date

2017-09-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2017-04-28

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
COOK INCORPORATED Registration: 1000393132 View Registration
Arrow International CR, a.s. Registration: 1000563940 View Registration
Cordis US Corp. Registration: 1016427 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
BIOTRONIK, INC. Registration: 1028232 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
Covidien Registration: 1219930 View Registration
MEDTRONIC VASCULAR Registration: 1220452 View Registration
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration
Covidien LLC Registration: 1282497 View Registration
C.R. BARD, INC. Registration: 1313046 View Registration
NUMED, INC. Registration: 1318694 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
BIOMERICS FMI Registration: 1646831 View Registration
Steritec Services, LLC Registration: 1647149 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
Cook Incorporated Registration: 1820334 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
ABBOTT VASCULAR Registration: 2024168 View Registration
Synergy Health AST, LLC Registration: 2030598 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration
MINNESOTA MEDTEC, INC. Registration: 2134626 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
Medtronic, Inc. Registration: 2183870 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
ABBOTT VASCULAR Registration: 2939561 View Registration
NIPRO CORPORATION Registration: 3000247873 View Registration
STERIS SPA Registration: 3002806603 View Registration
Sterigenics Germany GmbH Registration: 3002807090 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
SYNERGY HEALTH STERILISATION UK LTD Registration: 3002807315 View Registration
OrbusNeich Medical (Shenzhen) Co., Ltd. Registration: 3003775186 View Registration
Abbott Vascular Netherlands Registration: 3004091615 View Registration
NATEC MEDICAL LTD Registration: 3004415014 View Registration
NYPRO DR, LLC (Building 52) Registration: 3004730544 View Registration
COOK MEDICAL LLC Registration: 3005580113 View Registration
ABBOTT VASCULAR Registration: 3005718570 View Registration
Creagh Medical Ltd. Registration: 3005994106 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
NATEC MEDICAL LTD (Maurister) Registration: 3006550224 View Registration
Synergy Health AST, SRL Registration: 3007738736 View Registration
Curatia Medical Limited Registration: 3008261722 View Registration
Curatia Medical Co. Registration: 3008361782 View Registration
Verge Medical Inc. Registration: 3008700817 View Registration
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Abbott Vascular Registration: 3009564766 View Registration
EMERALD MEDICAL SERVICES PTE. LTD Registration: 3009965866 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
BROSMED MEDICAL CO.,LTD Registration: 3010391265 View Registration
Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
CYDONIA PHARMA SL Registration: 3011088743 View Registration
Rontis Hellas S.A. Registration: 3011142981 View Registration
CONTEGO MEDICAL, INC Registration: 3011471056 View Registration
MEDAS, INC. Registration: 3012050423 View Registration
STERI-TEK Registration: 3012448339 View Registration
MICRO MEDICAL SOLUTIONS INC Registration: 3013391155 View Registration
Eurofins Infinity Laboratory Group Inc. Registration: 3013944123 View Registration
Boston Scientific Medical Device (Malaysia) SDN BHD Registration: 3014222368 View Registration
KOSSEL MEDTECH (SUZHOU) CO., LTD. Registration: 3014390222 View Registration
RHENUS SE & CO. KG Registration: 3014656749 View Registration
SURMODICS, INC. Registration: 3014687026 View Registration
ORBUSNEICH MEDICAL CO. LTD (HONG KONG) Registration: 3015002281 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
Medline Industries (NAMIC Division) - Glen Falls Registration: 3015910259 View Registration
Penumbra Inc. Registration: 3016591327 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
NEXSTEP MEDICAL Registration: 3016927279 View Registration
Quasar MED IE (QIE) Limited Registration: 3019677404 View Registration
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Silk Road Medical Registration: 3022627847 View Registration
DK Medical Technology Co., Ltd. Registration: 3027343398 View Registration
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MOZARC MEDICAL US LLC Registration: 3030574705 View Registration
BIOTRONIK AG Registration: 8043892 View Registration
Kaneka Corporation Osaka Plant Registration: 9614654 View Registration
CLEARSTREAM TECHNOLOGIES LTD. Registration: 9616666 View Registration
BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
Medtronic Mexico S. de R.L. de CV Registration: 9617601 View Registration
NUMED CANADA, INC. Registration: 9618000 View Registration
Boston Scientific Limited Registration: 9681260 View Registration
LAKE REGION MEDICAL LIMITED Registration: 9681477 View Registration

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