FDA 510(k) Premarket Notification K012534: HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Boston Scientific Corporation Registration: 1000121056 View Registration

COOK INCORPORATED Registration: 1000393132 View Registration

AngioDynamics, Inc. Registration: 1000523114 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

MEDICAL ACTION INDUSTRIES, INC. 306 Registration: 1030451 View Registration

DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration

AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305 Registration: 1047429 View Registration

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

DeRoyal Industries, Inc. Registration: 1054241 View Registration

Sterigenics U.S. LLC Registration: 1054811 View Registration

DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration

REMINGTON MEDICAL, INC. Registration: 1056553 View Registration

Sterigenics U.S., LLC Registration: 1061124 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

GUIDEWIRE TECHNOLOGIES, INC. Registration: 1221806 View Registration

ACME-MONACO CORP. Registration: 1222301 View Registration

Vygon MFG Registration: 1223004 View Registration

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

Cerenovus, Inc. Registration: 1226348 View Registration

Covidien LLC Registration: 1282497 View Registration

ACME-MONACO CORP. Registration: 1293141 View Registration

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

ANGIODYNAMICS, INC. Registration: 1319211 View Registration

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

ARGON MEDICAL DEVICES, INC. Registration: 1417485 View Registration

MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration

Cardinal Health 200, LLC Registration: 1423537 View Registration

Isomedix Operations, Inc. Registration: 1450662 View Registration

ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration

MedXL Registration: 1644312 View Registration

GALT MEDICAL CORP. Registration: 1649395 View Registration

TORAY INTERNATIONAL AMERICA INC. Registration: 1649869 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1720929 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

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

Cook Incorporated Registration: 1820334 View Registration

CENTURION MEDICAL PRODUCTS, LP Registration: 1824619 View Registration

MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration

Sterigenics US LLC Registration: 2011171 View Registration

ABBOTT MEDICAL Registration: 2017865 View Registration

BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration

Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration

ABBOTT VASCULAR Registration: 2024168 View Registration

PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration

Medtronic Heart Valves Division Registration: 2025587 View Registration

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

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

Isomedix Operations, Inc. Registration: 2030624 View Registration

Boston Scientific Corporation Registration: 2124215 View Registration

Lake Region Medical Registration: 2126666 View Registration

Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration

INSITU TECHNOLOGIES, INC. Registration: 2134244 View Registration

BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration

RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 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

Medtronic, Inc. Registration: 2183870 View Registration

St. Jude Medical, Atrial Fibrillation Division, Inc. Registration: 2184149 View Registration

Sterigenics U.S., LLC Registration: 2219920 View Registration

VYGON USA Registration: 2245270 View Registration

Datascope Corp. Registration: 2248146 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

MARTECH MEDICAL PRODUCTS Registration: 2527072 View Registration

LYNX Medical Pennsylvania Registration: 2528981 View Registration

VOLCANO CORPORATION Registration: 2939520 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

INNOPEX LIMITED Registration: 3001124136 View Registration

TORAY MEDICAL CO., LTD. Registration: 3002244583 View Registration

Synergy Health Ireland Ltd Registration: 3002807314 View Registration

WILLIAM COOK EUROPE APS Registration: 3002808486 View Registration

PIOLAX MEDICAL DEVICES, INC. Registration: 3002917664 View Registration

STEREOTAXIS, INC. Registration: 3003084417 View Registration

EPFLEX FEINWERKTECHNIK GMBH Registration: 3003289691 View Registration

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration

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

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

GYRUS ACMI, INC. Registration: 3003790304 View Registration

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

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

Abbott Vascular Netherlands Registration: 3004091615 View Registration

Sterigenics US LLC Registration: 3004111573 View Registration

Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 View Registration

TRI-STATE DE MEXICO, S. DE R.L. DE C.V. Registration: 3004519921 View Registration

DEROYAL INTERCONTINENTAL, S.R.L. Registration: 3004605321 View Registration

SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 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

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

COOK MEDICAL LLC Registration: 3005580113 View Registration

ABBOTT VASCULAR Registration: 3005737652 View Registration

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

BRIVANT, LTD. Registration: 3006010712 View Registration

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

NeedleTech Products, Inc. Registration: 3006283319 View Registration

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

CEA Global Dominicana d.b.a. Nissha Medical Technologies Registration: 3006891611 View Registration

MEDISTRI SA Registration: 3006946276 View Registration

Merit Medical Nederland BV Registration: 3006950086 View Registration

Acme Monaco Asia Pte. Ltd. Registration: 3007064586 View Registration

Abbott Medical Registration: 3007113487 View Registration

ALLWELL MEDICAL CORPORATION Registration: 3007138831 View Registration

MERMAID MEDICAL A/S Registration: 3007146453 View Registration

SPECTRANETICS CORP. Registration: 3007284006 View Registration

SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. Registration: 3007361214 View Registration

Cerenovus, Inc. Registration: 3007628272 View Registration

Confluent Medical Technologies, Inc Registration: 3007635982 View Registration

Boston Scientific Corporation Registration: 3007695959 View Registration

Synergy Health AST, SRL Registration: 3007738736 View Registration

ADVANCED LIFESCIENCES PVT. LTD. Registration: 3007830707 View Registration

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Registration: 3008002401 View Registration

OPSENS INC. Registration: 3008061490 View Registration

MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration

Cerenovus, Inc. Registration: 3008264254 View Registration

Terumo Medical Canada, Inc. Registration: 3008307705 View Registration

Volcano Corporation Registration: 3008363989 View Registration

CENTURION MEDICAL PRODUCTS, LP Registration: 3008403546 View Registration

STRAUB MEDICAL AG Registration: 3008439199 View Registration

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

STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration

Stryker Neurovascular Registration: 3008853977 View Registration

HERAEUS MEDICAL COMPONENTS, LLC Registration: 3008988055 View Registration

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

HA2 MEDIZINTECHNIK GMBH Registration: 3009039068 View Registration

Yokowo Co., Ltd Registration: 3009092139 View Registration

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

Cardinal Health Costa Rica, S.A. Registration: 3009211636 View Registration

Medtronic Distribution Center Registration: 3009380063 View Registration

Volcano Corporation by Volcarica S.R.L. Registration: 3009490946 View Registration

Cook Medical EUDC GmbH Registration: 3009526575 View Registration

SCIENTIA VASCULAR Registration: 3009546466 View Registration

Abbott Vascular Registration: 3009564766 View Registration

Abbott Medical Registration: 3009600098 View Registration

ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration

Isomedix Operations Inc Registration: 3009888344 View Registration

RAPID-MEDICAL LTD Registration: 3009957947 View Registration

Teleflex LLC (NADC) Registration: 3010041511 View Registration

BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration

Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration

APPLIMED SA -CSSR Registration: 3010163695 View Registration

Synergy Health AST, SRL Registration: 3010273872 View Registration

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

SIGNA MEDICAL, INC. Registration: 3010419931 View Registration

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

Arrow International, LLC (subsidiary of Teleflex, Incorporated) Registration: 3010532612 View Registration

Merit Medical Systems, Inc. Registration: 3010665433 View Registration

HEALTH LINE INTERNATIONAL CORPORATION Registration: 3010882065 View Registration

Gyrus ACMI, Inc. Registration: 3011050570 View Registration

Teleflex Medical LLC Registration: 3011137372 View Registration

Beijing Target Medical Technologies Inc. Registration: 3011564431 View Registration

ATRICURE, INC. Registration: 3011706110 View Registration

MEDAS, INC. Registration: 3012050423 View Registration

CENTERLINE BIOMEDICAL Registration: 3012154226 View Registration

BIOMERICS Advanced Catheter Registration: 3012159165 View Registration

St. Jude Medical Registration: 3012179728 View Registration

FILMECC CO., LTD. Registration: 3012223769 View Registration

Stryker US Supply Chain Operations Registration: 3012497308 View Registration

Merit Medical Canada Ltd. Registration: 3012536737 View Registration

Stryker Neurovascular Registration: 3012931345 View Registration

FMD. Co., Ltd. Registration: 3013023134 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

NANO4IMAGING GMBH Registration: 3013595987 View Registration

Terumo Yamaguchi Corporation Registration: 3013611763 View Registration

PHENOX LIMITED Registration: 3013656790 View Registration

Heraeus Medical Components, SRL Registration: 3013666336 View Registration

Medical Components, Inc. Registration: 3013750125 View Registration

B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration

Zurich Medical Inc Registration: 3013943846 View Registration

BALT USA, LLC Registration: 3014162263 View Registration

Boston Scientific Medical Device (Malaysia) SDN BHD Registration: 3014222368 View Registration

Biomerics Cartago Registration: 3014246639 View Registration

MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration

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

Medline International B.V. Registration: 3014499739 View Registration

WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration

IMPERATIVE CARE INC. Registration: 3014590708 View Registration

RHENUS SE & CO. KG Registration: 3014656749 View Registration

FLAT MEDICAL CO., LTD. Registration: 3014716786 View Registration

FMD Co., Ltd. Okinawa Factory Registration: 3014977413 View Registration

CARDIO FLOW, INC. Registration: 3015124694 View Registration

Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 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

C2Dx, Inc. Registration: 3015489752 View Registration

NANO4IMAGING USA, LLC. Registration: 3015522130 View Registration

RAPID MEDICAL INC. Registration: 3015531723 View Registration

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

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

Medline Industries (NAMIC Division) - Glen Falls Registration: 3015910259 View Registration

Toyoflex Cebu Corporation Registration: 3016119728 View Registration

Schneider ASR B.V. Registration: 3016678045 View Registration

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

STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration

SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD. Registration: 3017961114 View Registration

SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD. Registration: 3018070217 View Registration

BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. Registration: 3018784828 View Registration

Boston Scientific Corporation Registration: 3019751610 View Registration

MEHOW INNOVATIVE (HUIZHOU) LTD. Registration: 3020283264 View Registration

PROCEDURE PRODUCTS, INC. Registration: 3020778 View Registration

AtriCure, Inc. Registration: 3020954746 View Registration

BAYLIS MEDICAL TECHNOLOGIES INC. Registration: 3020968442 View Registration

SUREAX MEDICAL, CORPORATION Registration: 3024682301 View Registration

EMBRACE MEDICAL LTD. Registration: 3024743081 View Registration

DEEPINTEC SCIENTIFIC CO., LTD Registration: 3026317086 View Registration

Mermaid Medical A/S (FL Site) Registration: 3027260597 View Registration

PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration

PHARMCO MEDICAL BV Registration: 3030447506 View Registration

ARTIRIA MEDICAL SA Registration: 3030452144 View Registration

MOZARC MEDICAL US LLC Registration: 3030574705 View Registration

AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration

Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration

SOLO PACE INC Registration: 3035372913 View Registration

Honduras Kitting, S.A. Registration: 3035642068 View Registration

Theragenics Costa Rica Limitada Registration: 3036802499 View Registration

ARBOR ENDOVASCULAR Registration: 3039642752 View Registration

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042175841 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

Covidien Registration: 9610849 View Registration

NIPRO MEDICAL INDUSTRIES LTD. Registration: 9611446 View Registration

Sterigenics EO Canada, Inc. Registration: 9611665 View Registration

TORAY INDUSTRIES, INC. SETA PLANT Registration: 9612812 View Registration

B. BRAUN DOMINICAN REPUBLIC INC. Registration: 9614279 View Registration

TORAY INDUSTRIES, INC. Registration: 9614758 View Registration

Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration

MERIT MEDICAL IRELAND, LTD Registration: 9616662 View Registration

Boston Scientific Limited Registration: 9616684 View Registration

BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration

Venusa de Mexico S. de R.L de C.V Registration: 9680001 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

HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

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