FDA 510(k) Premarket Notification K034025: NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

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

OSCOR INC. Registration: 1035166 View Registration

DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration

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

DeRoyal Industries, Inc. Registration: 1054241 View Registration

DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration

REMINGTON MEDICAL, INC. Registration: 1056553 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

ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration

ABIOMED, INC. Registration: 1220648 View Registration

Teleflex Medical LLC Registration: 1221019 View Registration

FREUDENBERG MEDICAL, LLC Registration: 1222140 View Registration

Vygon MFG Registration: 1223004 View Registration

SPECTRA MEDICAL DEVICES, LLC Registration: 1224960 View Registration

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

CARDIOFOCUS, INC. Registration: 1225698 View Registration

Covidien LLC Registration: 1282497 View Registration

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

NUMED, INC. Registration: 1318694 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

CAREFUSION 2200, INC. Registration: 1423507 View Registration

Cardinal Health 200, LLC Registration: 1423537 View Registration

Isomedix Operations, Inc. Registration: 1424263 View Registration

Isomedix Operations, Inc. Registration: 1450662 View Registration

ISOMEDIX OPERATIONS INC Registration: 1526711 View Registration

ICU Medical, Inc. Registration: 1526863 View Registration

ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration

CAREFUSION 2200, INC. Registration: 1625685 View Registration

ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration

MedXL Registration: 1644312 View Registration

Steritec Services, LLC Registration: 1647149 View Registration

GALT MEDICAL CORP. Registration: 1649395 View Registration

Isomedix Operations Inc. Registration: 1650907 View Registration

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. Registration: 1710034 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

CENTURION MEDICAL PRODUCTS, LP Registration: 1824619 View Registration

HART ENTERPRISES, INC. Registration: 1828424 View Registration

RLS Interventional Inc. DBA Inrad Registration: 1835568 View Registration

Cardinal Health Registration: 1921846 View Registration

MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration

Sterigenics US LLC Registration: 2011171 View Registration

EDWARDS LIFESCIENCES LLC Registration: 2015691 View Registration

ABBOTT MEDICAL Registration: 2017865 View Registration

BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration

ABBOTT VASCULAR Registration: 2024168 View Registration

PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration

Sterigenics U.S., LLC Registration: 2029015 View Registration

IRVINE BIOMEDICAL. INC. Registration: 2030404 View Registration

Synergy Health AST, LLC Registration: 2030598 View Registration

Isomedix Operations, Inc. Registration: 2030624 View Registration

Isomedix Operations Inc. Registration: 2032112 View Registration

Stryker Sustainability Solutions Phoenix Registration: 2090040 View Registration

Boston Scientific Corporation Registration: 2124215 View Registration

INSITU TECHNOLOGIES, INC. Registration: 2134244 View Registration

BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration

VASCULAR SOLUTIONS LLC Registration: 2134812 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

VYGON USA Registration: 2245270 View Registration

Isomedix Operations Inc. Registration: 2246552 View Registration

Datascope Corp. Registration: 2248146 View Registration

DEROYAL INDUSTRIES, INC. Registration: 2320762 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

EDWARDS LIFESCIENCES TECHNOLOGY SARL Registration: 2648045 View Registration

ABBOTT VASCULAR Registration: 2939561 View Registration

Medtronic Vascular Registration: 2953200 View Registration

Sterigenics U.S. LLC Registration: 2953359 View Registration

IMPERIAL TRADING LIMITED Registration: 3000268902 View Registration

INNOPEX LIMITED Registration: 3001124136 View Registration

SURMODICS, INC. Registration: 3001374820 View Registration

Becton Dickinson Medical Devices Co., Ltd. Suzhou Registration: 3002601200 View Registration

Medtronic CryoCath LP Registration: 3002648230 View Registration

Synergy Health Ireland Ltd Registration: 3002807314 View Registration

Dimequip Registration: 3002808467 View Registration

BIOCARDIA, INC. Registration: 3003610571 View Registration

Contract Medical International GmbH Registration: 3003637635 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

AMECO MEDICAL INDUSTRIES Registration: 3004134316 View Registration

CREGANNA MEDICAL IRELAND LIMITED Registration: 3004193842 View Registration

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

Cirtec Medical Registration: 3004737415 View Registration

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

OSCOR CARIBE LLC Registration: 3004785273 View Registration

PENUMBRA, INC. Registration: 3005168196 View Registration

Teleflex Medical OEM LLC Registration: 3005232773 View Registration

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

COOK MEDICAL LLC Registration: 3005580113 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

NeedleTech Products, Inc. Registration: 3006283319 View Registration

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

Merit Medical Nederland BV Registration: 3006950086 View Registration

NEO MEDICAL INC. Registration: 3007207906 View Registration

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

KARDIUM Inc. Registration: 3007603855 View Registration

Boston Scientific Corporation Registration: 3007695959 View Registration

FOOTPRINT MEDICAL INC. Registration: 3007697249 View Registration

ADVANCED LIFESCIENCES PVT. LTD. Registration: 3007830707 View Registration

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

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

MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration

Curatia Medical Limited Registration: 3008261722 View Registration

Terumo Medical Canada, Inc. Registration: 3008307705 View Registration

Freudenberg Medical Ireland Limited Registration: 3008328690 View Registration

Curatia Medical Co. Registration: 3008361782 View Registration

CENTURION MEDICAL PRODUCTS, LP Registration: 3008403546 View Registration

Abbott Medical Costa Rica Ltda. Registration: 3008452825 View Registration

Edwards Lifesciences LLC Registration: 3008500478 View Registration

PDV MedTech Registration: 3008514120 View Registration

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

Stryker Neurovascular Registration: 3008853977 View Registration

BIOMERICS Registration: 3008998256 View Registration

RESPICARDIA, INC. Registration: 3009144177 View Registration

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

Stryker Sustainability Solutions Registration: 3009350690 View Registration

SHANGHAI MICROPORT EP MEDTECH CO., LTD. Registration: 3009393076 View Registration

Primo Medical Group, Inc Registration: 3009420598 View Registration

CIRCA Scientific, Inc. Registration: 3009437315 View Registration

Integra Biotechnical, SA de CV Registration: 3009746061 View Registration

Isomedix Operations Inc Registration: 3009888344 View Registration

BLUE LINE STERILIZATION SERVICES Registration: 3009905888 View Registration

Teleflex LLC (NADC) Registration: 3010041511 View Registration

YCH DISTRIPARK SDN BHD Registration: 3010055973 View Registration

BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration

BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. Registration: 3010141307 View Registration

Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration

SYNAPTIC MEDICAL LIMITED Registration: 3010200163 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

VASCUTECH MEDICAL, LLC Registration: 3010391198 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

NextPhase Medical Devices Mexico LLC Registration: 3010882708 View Registration

CUSTOM TUBE MANUFACTURING LLC Registration: 3010966701 View Registration

Nypro Inc (Maple Grove) Registration: 3011024991 View Registration

Endologix LLC Registration: 3011063223 View Registration

Teleflex Medical LLC Registration: 3011137372 View Registration

Vygon Verneuil Registration: 3011237770 View Registration

CLEAR GUIDE MEDICAL Registration: 3011396687 View Registration

Beijing Target Medical Technologies Inc. Registration: 3011564431 View Registration

INNOVATIVE HEALTH, LLC. Registration: 3011610434 View Registration

Theragenics Costa Rica Limitada Registration: 3011623145 View Registration

Merit Maquiladora Mexico, S. DE R.L. DE C.V. Registration: 3011642792 View Registration

LAUNCH DEVELOPMENT Registration: 3011657089 View Registration

DYLAN LUCAS INTERNATIONAL INC Registration: 3011689956 View Registration

AGILE MV Registration: 3011752740 View Registration

MEDAS, INC. Registration: 3012050423 View Registration

St. Jude Medical Registration: 3012179728 View Registration

ICU Medical, Inc. Registration: 3012307300 View Registration

Merit Medical Canada Ltd. Registration: 3012536737 View Registration

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

ABBOTT MEDICAL Registration: 3013288201 View Registration

BIOSENSE WEBSTER, INC. Registration: 3013300026 View Registration

SYNAPTIC MEDICAL CORPORATION Registration: 3013400708 View Registration

CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration

Heraeus Medical Components, SRL Registration: 3013666336 View Registration

Penumbra Inc. Registration: 3013758550 View Registration

B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration

PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC Registration: 3013986346 View Registration

GMED Healthcare BVBA ( a Johnson & Johnson Company) Registration: 3014272734 View Registration

RHENUS SE & CO. KG Registration: 3014656749 View Registration

SURMODICS, INC. Registration: 3014687026 View Registration

Gore European Warehouse Support Registration: 3015138222 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

Penumbra Inc. Registration: 3015615738 View Registration

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

CENTERPOINT SYSTEMS LLC Registration: 3015970743 View Registration

Penumbra Inc. Registration: 3016591327 View Registration

Schneider ASR B.V. Registration: 3016678045 View Registration

SAINT JONES MANAGEMENT LP EOOD Registration: 3016904853 View Registration

SWITCHBACK MEDICAL Registration: 3016986313 View Registration

LARK INDUSTRIES Registration: 3017060084 View Registration

CPE1, LLC DBA Greatbatch Medical Registration: 3017168767 View Registration

Edwards Lifesciences Ireland Limited Registration: 3017298588 View Registration

Harsoria Healthcare Pvt. Ltd. (Unit-2) Registration: 3017406698 View Registration

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

CARDIOVIA Ltd. Registration: 3017689643 View Registration

Boston Scientific Corporation Registration: 3019751610 View Registration

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

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

Inari Medical, Inc. Registration: 3020347218 View Registration

AtriCure, Inc. Registration: 3020954746 View Registration

BAYLIS MEDICAL TECHNOLOGIES INC. Registration: 3020968442 View Registration

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

KHTP STERILISATION SERVICES SDN. BHD. Registration: 3022518300 View Registration

TIANJIN DEMAX MEDICAL TECHNOLOGY CO., LTD. Registration: 3022815697 View Registration

EOSOLUTIONS, CORP. Registration: 3025028711 View Registration

BOSTON SCIENTIFIC CORPORATION Registration: 3025341484 View Registration

VIZARAMED, INC. Registration: 3027366703 View Registration

TZ MEDICAL, INC. Registration: 3027815 View Registration

Teleflex LLC Registration: 3030236028 View Registration

PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration

PHARMCO MEDICAL BV Registration: 3030447506 View Registration

MOZARC MEDICAL US LLC Registration: 3030574705 View Registration

AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration

ZENITH 11 MEDICAL LLC Registration: 3031282706 View Registration

ENABLECV, LLC Registration: 3031571797 View Registration

INQUIS MEDICAL, INC. Registration: 3031823122 View Registration

DAMBO SRL Registration: 3031983053 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

Theragenics Costa Rica Limitada Registration: 3036802499 View Registration

SOUTH53 Registration: 3037047821 View Registration

TIANJIN ETHYLENE OXIDE STERILIZATION TECHNOLOGY CO.,LTD. Registration: 3037050339 View Registration

CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O. Registration: 3038188187 View Registration

Abbott Medical Mexico, S. de R.L. de C.V. Registration: 3038966633 View Registration

LIGHTNINGCATH Registration: 3039454510 View Registration

PULNOVO MEDICAL (WUXI) CO., LTD. Registration: 3041086754 View Registration

CARDIOCYCLE MEDICAL(SUZHOU) CO.,LTD. Registration: 3042279517 View Registration

GOODWILL COMMERCIAL SERVICES Registration: 3043337628 View Registration

TERUMO CORP. Registration: 8010026 View Registration

Merit Medical Singapore Pte. Ltd. Registration: 8020616 View Registration

VYGON S A Registration: 8020785 View Registration

BIOTRONIK AG Registration: 8043892 View Registration

B. BRAUN MELSUNGEN AG Registration: 9610825 View Registration

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. Registration: 9610847 View Registration

PAJUNK GMBH MEDIZINTECHNOLOGIE Registration: 9611612 View Registration

B. BRAUN MEDICAL INDUSTRIES SDN. BHD. Registration: 9612086 View Registration

TOGO MEDIKIT CO., LTD. Registration: 9612126 View Registration

MEDTRONIC IRELAND Registration: 9612164 View Registration

VYGON Germany GmbH Registration: 9612433 View Registration

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

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

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

CLEARSTREAM TECHNOLOGIES LTD. Registration: 9616666 View Registration

TELEFLEX MEDICAL Registration: 9616683 View Registration

PFM Medical GmbH Registration: 9617465 View Registration

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

ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration

BIOSENSE WEBSTER, INC. Registration: 9673241 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

NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

Submission Details & Decision

Related Establishments / Registrations

Public Record Disclaimer