FDA 510(k) Premarket Notification K070372: GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610

Boston Scientific Corporation Registration: 1000121056 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

Sterigenics U.S., LLC Registration: 1018470 View Registration

BIOTRONIK, INC. Registration: 1028232 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration

STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration

Sterigenics US LLC Registration: 1058584 View Registration

Sterigenics U.S., LLC Registration: 1061124 View Registration

INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration

ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration

TERUMO MEDICAL CORP. Registration: 1118880 View Registration

STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration

MEDTRONIC VASCULAR Registration: 1220452 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration

Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration

C.R. BARD, INC. Registration: 1313046 View Registration

NUMED, INC. Registration: 1318694 View Registration

Sterigenics U.S., LLC Registration: 1319639 View Registration

Isomedix Operations, Inc. Registration: 1450662 View Registration

Sterigenics US, LLC Registration: 1526534 View Registration

ICU Medical, Inc. Registration: 1526863 View Registration

NORMAN NOBLE, INC. Registration: 1531050 View Registration

ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration

ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration

BIOMERICS FMI Registration: 1646831 View Registration

Steritec Services, LLC Registration: 1647149 View Registration

MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration

Sterigenics U.S., LLC Registration: 1721676 View Registration

Sterigenics U.S., LLC Registration: 1721686 View Registration

MEDRON, LLC Registration: 1722746 View Registration

Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration

Cook Incorporated Registration: 1820334 View Registration

BOSTON SCIENTIFIC CORPORATION Registration: 1828132 View Registration

MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration

Sterigenics US LLC Registration: 2011171 View Registration

W. L. GORE & ASSOCIATES, INC Registration: 2017233 View Registration

ABBOTT MEDICAL Registration: 2017865 View Registration

BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration

AXIOM MEDICAL, INC. Registration: 2020735 View Registration

Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration

ABBOTT VASCULAR Registration: 2024168 View Registration

PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration

BREVET INC. Registration: 2025870 View Registration

BIOSEAL Registration: 2027062 View Registration

APPLIED MEDICAL RESOURCES CORP. Registration: 2027111 View Registration

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 2029214 View Registration

Sterigenics U.S., LLC Registration: 2029275 View Registration

Synergy Health AST, LLC Registration: 2030598 View Registration

Isomedix Operations, Inc. Registration: 2030624 View Registration

Isomedix Operations Inc. Registration: 2032112 View Registration

Boston Scientific Corporation Registration: 2124215 View Registration

Lake Region Medical Registration: 2126666 View Registration

BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration

VASCULAR SOLUTIONS LLC Registration: 2134812 View Registration

Abbott Medical Registration: 2135147 View Registration

MEDTRONIC, INC. Registration: 2182208 View Registration

St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2182269 View Registration

Isomedix Operations, Inc. Registration: 2183744 View Registration

Greatbatch Medical Registration: 2183787 View Registration

Medtronic, Inc. Registration: 2183870 View Registration

MEDTRONIC PERFUSION SYSTEMS Registration: 2184009 View Registration

MEDICAL COMPONENTS INC Registration: 2518902 View Registration

B. BRAUN MEDICAL INC. Registration: 2521402 View Registration

B. BRAUN US DEVICE MANUFACTURING LLC Registration: 2523676 View Registration

LYNX Medical Pennsylvania Registration: 2528981 View Registration

EDWARDS LIFESCIENCES TECHNOLOGY SARL Registration: 2648045 View Registration

Boston Scientific Corporation Registration: 2648729 View Registration

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA Registration: 2649622 View Registration

ABBOTT VASCULAR Registration: 2939561 View Registration

Medtronic Vascular Registration: 2953200 View Registration

Philips Electronics Ltd Registration: 3000126629 View Registration

NIPRO CORPORATION Registration: 3000247873 View Registration

IMPERIAL TRADING LIMITED Registration: 3000268902 View Registration

FUJI SYSTEMS CORPORATION, Shirakawa Plant Registration: 3000308637 View Registration

INNOPEX LIMITED Registration: 3001124136 View Registration

SURMODICS, INC. Registration: 3001374820 View Registration

STERIS SPA Registration: 3002806603 View Registration

Sterigenics Germany GmbH Registration: 3002807090 View Registration

Synergy Health Ireland Ltd Registration: 3002807314 View Registration

BIOCARDIA, INC. Registration: 3003610571 View Registration

ASAHI INTECC CO., LTD. Registration: 3003775027 View Registration

OrbusNeich Medical (Shenzhen) Co., Ltd. Registration: 3003775186 View Registration

ASAHI INTECC (THAILAND) CO., LTD. Registration: 3003780911 View Registration

Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration

W. L. GORE & ASSOCIATES, INC. Registration: 3003910212 View Registration

MARTECH MEDICAL PRODUCTS S. DE RL. DE CV. Registration: 3003915875 View Registration

Medtronic Grand Rapids Registration: 3003955307 View Registration

Lake Region Medical Registration: 3004063494 View Registration

Abbott Vascular Netherlands Registration: 3004091615 View Registration

Sterigenics US LLC Registration: 3004111573 View Registration

NATEC MEDICAL LTD Registration: 3004415014 View Registration

ASAHI INTECC USA, INC. Registration: 3004718255 View Registration

Cardiovascular Systems Incorporated Registration: 3004742232 View Registration

STERIS AST CZ s.r.o. Registration: 3004784537 View Registration

BOSTON SCIENTIFIC CORPORATION Registration: 3004859241 View Registration

MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration

Abbott Vascular Registration: 3005070406 View Registration

PENUMBRA, INC. Registration: 3005168196 View Registration

Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration

Teleflex Medical OEM LLC Registration: 3005232773 View Registration

ARROTEK MEDICAL LTD Registration: 3005255160 View Registration

St. Jude Medical, Cardiology Division, Inc. Registration: 3005334138 View Registration

COOK MEDICAL LLC Registration: 3005580113 View Registration

PENDRACARE INTERNATIONAL B.V. Registration: 3005635992 View Registration

ABBOTT VASCULAR Registration: 3005718570 View Registration

Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration

Creagh Medical Ltd. Registration: 3005994106 View Registration

C.R. BARD, INC. Registration: 3006082230 View Registration

SEISA MEDICAL INC Registration: 3006131984 View Registration

Bard Access Systems, Inc. Registration: 3006260740 View Registration

Arrow International C.R. a.s. Registration: 3006425876 View Registration

Covidien Medical Products (Shanghai) Manufacturing LLC Registration: 3006451981 View Registration

NATEC MEDICAL LTD (Maurister) Registration: 3006550224 View Registration

HAOLANG TECHNOLOGY (FOSHAN) LIMITED CORPORATION Registration: 3006942602 View Registration

MEDISTRI SA Registration: 3006946276 View Registration

Merit Medical Nederland BV Registration: 3006950086 View Registration

Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration

Abbott Medical Registration: 3007113487 View Registration

NEO MEDICAL INC. Registration: 3007207906 View Registration

SPECTRANETICS CORP. Registration: 3007284006 View Registration

W. L. GORE & ASSOCIATES, INC. Registration: 3007284313 View Registration

Cerenovus, Inc. Registration: 3007628272 View Registration

Synergy Health AST, SRL Registration: 3007738736 View Registration

IMDS Operations B.V. Registration: 3007740583 View Registration

Greatbatch Medical, S. de R.L. de C.V. Registration: 3007882731 View Registration

MARVAO MEDICAL DEVICES LTD. Registration: 3008110587 View Registration

MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration

Curatia Medical Limited Registration: 3008261722 View Registration

Cerenovus, Inc. Registration: 3008264254 View Registration

Terumo Medical Canada, Inc. Registration: 3008307705 View Registration

Curatia Medical Co. Registration: 3008361782 View Registration

LIFETECH SCIENTIFIC (SHENZHEN) CO,.LTD Registration: 3008423561 View Registration

GOALS STERILIZATION CO., LTD Registration: 3008573567 View Registration

I-Tek Medical, Inc. Registration: 3008627763 View Registration

Verge Medical Inc. Registration: 3008700817 View Registration

REFLOW MEDICAL, INC Registration: 3008789872 View Registration

CARDIOVASCULAR SYSTEMS INCORPORATED Registration: 3008814558 View Registration

STERIS Sterilization Technologies (Suzhou) Ltd Registration: 3008824097 View Registration

STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration

Stryker Neurovascular Registration: 3008853977 View Registration

Stryker Neurovascular Registration: 3008881809 View Registration

Nitinol Devices & Components Costa Rica, S. R. L. Registration: 3009018440 View Registration

Applied Medical Distribution Center Registration: 3009051888 View Registration

ASAHI INTECC HANOI CO., LTD. Registration: 3009121749 View Registration

RESPICARDIA, INC. Registration: 3009144177 View Registration

Medtronic Distribution Center Registration: 3009380063 View Registration

SCIENTIA VASCULAR Registration: 3009546466 View Registration

Abbott Vascular Registration: 3009564766 View Registration

ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration

Synergy Health Ede BV Registration: 3009756327 View Registration

QXMEDICAL, LLC Registration: 3009766315 View Registration

Isomedix Operations Inc Registration: 3009888344 View Registration

BLUE LINE STERILIZATION SERVICES Registration: 3009905888 View Registration

EMERALD MEDICAL SERVICES PTE. LTD Registration: 3009965866 View Registration

Teleflex LLC (NADC) Registration: 3010041511 View Registration

MicroVention Costa Rica S.R.L. Registration: 3010079067 View Registration

Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration

Synergy Health Westport Ltd Registration: 3010173425 View Registration

Synergy Health AST, SRL Registration: 3010273872 View Registration

AvailMed S.A.De C.V. Registration: 3010291427 View Registration

STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD Registration: 3010370269 View Registration

SIGNA MEDICAL, INC. Registration: 3010419931 View Registration

STERIS TOMOE SINGAPORE PTE LTD Registration: 3010421104 View Registration

Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration

Merit Medical Systems, Inc. Registration: 3010665433 View Registration

HEALTH LINE INTERNATIONAL CORPORATION Registration: 3010882065 View Registration

Surefire Medical, Inc. Registration: 3010909876 View Registration

CYDONIA PHARMA SL Registration: 3011088743 View Registration

Teleflex Medical LLC Registration: 3011137372 View Registration

Rontis Hellas S.A. Registration: 3011142981 View Registration

ATRICURE, INC. Registration: 3011706110 View Registration

MEDAS, INC. Registration: 3012050423 View Registration

Synergy Health AST, LLC Registration: 3012102437 View Registration

CENTERLINE BIOMEDICAL Registration: 3012154226 View Registration

BIOMERICS Advanced Catheter Registration: 3012159165 View Registration

St. Jude Medical Registration: 3012179728 View Registration

Resolution Medical Registration: 3012266672 View Registration

PRYTIME MEDICAL DEVICES, INC. Registration: 3012279212 View Registration

ICU Medical, Inc. Registration: 3012307300 View Registration

STERI-TEK Registration: 3012448339 View Registration

SANICURE BV Registration: 3012494290 View Registration

Stryker US Supply Chain Operations Registration: 3012497308 View Registration

Merit Medical Canada Ltd. Registration: 3012536737 View Registration

WALLABY MEDICAL Registration: 3012543881 View Registration

Stryker Neurovascular Registration: 3012931345 View Registration

HEXACATH Registration: 3013134719 View Registration

Arrow International LLC (subsidiary of Teleflex Incorporated) Registration: 3013162291 View Registration

ABBOTT MEDICAL Registration: 3013288201 View Registration

MicroVention, Inc. Registration: 3013556777 View Registration

CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration

Penumbra Inc. Registration: 3013758550 View Registration

B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration

M4D LLC Registration: 3013858269 View Registration

Eurofins Infinity Laboratory Group Inc. Registration: 3013944123 View Registration

BALT USA, LLC Registration: 3014162263 View Registration

ALEMBIC LLC Registration: 3014211783 View Registration

BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration

VESALIO Registration: 3014498720 View Registration

WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration

IMPERATIVE CARE INC. Registration: 3014590708 View Registration

Shanghai Wallaby Medical Technologies CO., Inc. Registration: 3014644549 View Registration

RHENUS SE & CO. KG Registration: 3014656749 View Registration

SURMODICS, INC. Registration: 3014687026 View Registration

FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant Registration: 3014766734 View Registration

Creganna Medical S. R. L Registration: 3014779787 View Registration

ORBUSNEICH MEDICAL CO. LTD (HONG KONG) Registration: 3015002281 View Registration

SHOCKWAVE MEDICAL, INC. Registration: 3015053858 View Registration

MERAQI MEDICAL, INC. Registration: 3015060261 View Registration

Merit Medical Asia Company Limited Registration: 3015225571 View Registration

Merit Medical UK Limited Registration: 3015309643 View Registration

CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 3015550451 View Registration

Penumbra Inc. Registration: 3015615738 View Registration

Arrow International, LLC (subsidiary of Teleflex Incorporated) Registration: 3015859709 View Registration

CENTERPOINT SYSTEMS LLC Registration: 3015970743 View Registration

Toyoflex Cebu Corporation Registration: 3016119728 View Registration

PROVISIO MEDICAL INC. Registration: 3016171942 View Registration

Okami Medical Inc. Registration: 3016444913 View Registration

Route 92 Medical, Head Quarters Registration: 3016522967 View Registration

NeuroVasc Technologies, Inc. Registration: 3016540856 View Registration

Penumbra Inc. Registration: 3016591327 View Registration

Schneider ASR B.V. Registration: 3016678045 View Registration

CATHX MEDICAL INC Registration: 3016704395 View Registration

HAOLANG MEDICAL USA CORPORATION Registration: 3016727301 View Registration

BMC MEDICAL MANUFACTURING S.A. DE C.V. Registration: 3016829855 View Registration

TRANSIT SCIENTIFIC, LLC Registration: 3016948450 View Registration

CPE1, LLC DBA Greatbatch Medical Registration: 3017168767 View Registration

VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration

Wuxi Goals Medical Technology Co., Ltd. Registration: 3017262662 View Registration

BEND IT TECHNOLOGIES LTD. Registration: 3017278832 View Registration

SEIGLA MEDICAL, INC. Registration: 3017708755 View Registration

Boston Scientific Corporation Registration: 3019751610 View Registration

CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration

Inari Medical, Inc. Registration: 3020347218 View Registration

Elumn8 Medical, Inc Registration: 3020677060 View Registration

Abbott Medical Registration: 3020950818 View Registration

Q'apel Medical, Inc. Registration: 3020954126 View Registration

AtriCure, Inc. Registration: 3020954746 View Registration

QUASAR MEDICAL (SINGAPORE) PTE. LTD. Registration: 3021951050 View Registration

SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CORPORATION LIMITED Registration: 3024801436 View Registration

EOSOLUTIONS, CORP. Registration: 3025028711 View Registration

BOSTON SCIENTIFIC CORPORATION Registration: 3025341484 View Registration

Prytime Medical Devices, Inc. Registration: 3026788751 View Registration

Reflow Medical Registration: 3027058844 View Registration

MADURO MEDICAL, INC. Registration: 3027319104 View Registration

DK Medical Technology Co., Ltd. Registration: 3027343398 View Registration

Route 92 Medical, West Jordan Registration: 3030088112 View Registration

Teleflex LLC Registration: 3030236028 View Registration

AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration

TORO NEUROVASCULAR, INC. Registration: 3031311812 View Registration

PIRAEUS MEDICAL, INC. Registration: 3031768596 View Registration

CROSSROADS NEUROVASCULAR Registration: 3032047719 View Registration

VANTIS VASCULAR, INC. Registration: 3032277090 View Registration

BECTON, DICKINSON AND COMPANY Registration: 3032916632 View Registration

Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration

GAMAMED VASCULAR SYSTEMS INC. Registration: 3035111606 View Registration

BASIS MEDICAL Registration: 3038912532 View Registration

CORVITEX CORPORATION Registration: 3039062605 View Registration

TERUMO CORP. Registration: 8010026 View Registration

BALT EXTRUSION Registration: 8023054 View Registration

BIOTRONIK AG Registration: 8043892 View Registration

BIOTRONIK SE & CO. KG Registration: 9610139 View Registration

MEDTRONIC IRELAND Registration: 9612164 View Registration

Kaneka Corporation Osaka Plant Registration: 9614654 View Registration

Cardinal Health Mexico 244 S de RL de CV Registration: 9616099 View Registration

CLEARSTREAM TECHNOLOGIES LTD. Registration: 9616666 View Registration

Boston Scientific Limited Registration: 9616684 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

Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration

Boston Scientific Limited Registration: 9681260 View Registration

LAKE REGION MEDICAL LIMITED Registration: 9681477 View Registration

ASHITAKA FACTORY OF TERUMO CORP. Registration: 9681834 View Registration

SEI Medical S.A. de C.V. Registration: 9710641 View Registration

GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610

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