FDA Product Code
FDA Product Code DXC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4450
510(k) Clearances — 205 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2026-07-22 | Special | PDF ↗ |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | 2026-06-05 | Traditional | PDF ↗ |
| K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | 2026-05-22 | Traditional | PDF ↗ |
| K254060 | Life Saving Tourniquet | TW Medical | 2026-04-03 | Traditional | PDF ↗ |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC | 2025-12-31 | Traditional | PDF ↗ |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Medline Industries, LP | 2025-11-20 | Traditional | PDF ↗ |
| K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | 2024-01-18 | Traditional | PDF ↗ |
| K230281 | PICOCLAMP | Kono Seisakusho Co., Ltd. | 2023-10-23 | Traditional | PDF ↗ |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Compression Works, Inc. | 2023-03-03 | Traditional | PDF ↗ |
| K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023-02-28 | Special | PDF ↗ |
| K222182 | Radial Artery Compression Tourniquets | Beijing Demax Medical Technology Co.,Ltd | 2023-01-04 | Traditional | PDF ↗ |
| K221843 | GEM Biover Microvascular Clamps | Synovis Micro Companies Alliance, Inc. | 2022-09-14 | Special | PDF ↗ |
| K213531 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2021-12-20 | Traditional | PDF ↗ |
| K210681 | SiteSeal SV | Ensite Vascular | 2021-04-06 | Special | PDF ↗ |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 | Traditional | PDF ↗ |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | Carefusion 2200, Inc. | 2021-03-04 | Special | PDF ↗ |
| K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021-02-17 | Traditional | PDF ↗ |
| K203803 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2021-01-26 | Traditional | PDF ↗ |
| K201695 | Patent Hemostasis Band (PH Band) | Medical Ingenuities | 2020-10-30 | Traditional | PDF ↗ |
| K192413 | SiteSeal Femoral Compression Device | Ensite Vacular, LLC | 2020-03-31 | Traditional | PDF ↗ |
| K191827 | Sunmed Disposable Angio-Closure Pads | Sunny Medical Device (Shenzhen) Co., Ltd. | 2020-03-16 | Traditional | PDF ↗ |
| K190351 | Site Seal SV | Ensite Vascular | 2019-07-02 | Traditional | PDF ↗ |
| K190318 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2019-03-14 | Traditional | PDF ↗ |
| K180723 | PreludeSYNC DISTAL Radial Compression System | Merit Medical Systems, Inc. | 2018-04-17 | Special | PDF ↗ |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | Tz Medical, Inc. | 2018-01-10 | Traditional | PDF ↗ |
| K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | Tricol Biomedical, Inc. | 2017-08-29 | Traditional | PDF ↗ |
| K163693 | IntraClude Intra-Aortic Occlusion Device | Edwards Lifesciences, LLC | 2017-01-26 | Special | PDF ↗ |
| K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017-01-25 | Traditional | PDF ↗ |
| K162027 | TRAcelet Compression Device | Medtronic Vascular | 2016-10-21 | Traditional | PDF ↗ |
| K161315 | Vein Clamps, Artery Clamps | Aros Surgical Instruments Corporation | 2016-08-18 | Special | PDF ↗ |
| K153259 | VasoStat Hemostasis Device | Forge Medical, Inc. | 2016-01-06 | Traditional | PDF ↗ |
| K152525 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2015-11-10 | Traditional | PDF ↗ |
| K151363 | Zephyr Vascular Compression Device | Advanced Vascular Dynamics | 2015-07-31 | Traditional | PDF ↗ |
| K143078 | Bookwalter Gordon Adjustable Compression Element | Symmetry Surgical | 2015-05-14 | Traditional | PDF ↗ |
| K150813 | iTClamp50 | Innovative Trauma Care, Inc. | 2015-04-30 | Special | PDF ↗ |
| K141685 | CROC | Combat Medical Systems, LLC | 2015-01-26 | Traditional | PDF ↗ |
| K142122 | RADAR VASCULAR COMPRESSION DEVICE | Advanced Vascular Dynamics | 2014-12-04 | Abbreviated | PDF ↗ |
| K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-10-23 | Traditional | PDF ↗ |
| K140805 | ITCLAMP 50 | Innovative Trauma Care, Inc. | 2014-10-09 | Traditional | PDF ↗ |
| K132293 | SYVEK RADIAL BAND | Marine Polymer Technologies | 2014-07-31 | Traditional | PDF ↗ |
| K133029 | ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE | Compression Works, LLC | 2013-12-06 | Traditional | PDF ↗ |
| K132651 | ITCLAMP 50 | Innovative Trauma Care, Inc. | 2013-10-28 | Traditional | PDF ↗ |
| K131411 | COSEAL | Jilin Coronado Medical , Ltd. | 2013-09-26 | Traditional | PDF ↗ |
| K132175 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | Edwards Lifesciences, LLC | 2013-09-13 | Traditional | PDF ↗ |
| K123571 | CARDIO VISION MICS AORTIC CLAMPS | Cardiomedical GmbH | 2013-08-01 | Traditional | PDF ↗ |
| K131561 | SAM JUNCTIONAL TOURNIQUET | Sam Medical Products | 2013-07-24 | Traditional | PDF ↗ |
| K130382 | HEARTSTRING III PROXIMAL SEAL SYSTEM | Boston Scientific Corporation | 2013-06-05 | Traditional | PDF ↗ |
| K123041 | VASOSTAT HEMOSTASIS DEVICE | Forge Medical, Inc. | 2013-05-29 | Traditional | PDF ↗ |
| K123551 | ITCLAMP 50 | Innovative Trauma Care, Inc. | 2013-05-14 | Traditional | PDF ↗ |
| K123077 | VASCULAR CLAMPS | Hebumedical GmbH | 2013-05-14 | Traditional | PDF ↗ |
| K130482 | COMBAT READY CLAMP | Combat Medical Systems, LLC | 2013-04-29 | Traditional | PDF ↗ |
| K130124 | CATALYST II AND III | Cardiva Medical, Inc. | 2013-03-14 | Traditional | PDF ↗ |
| K123694 | SAM JUNCTIONAL TOURNIQUET | Sam Medical Products | 2013-03-07 | Traditional | PDF ↗ |
| K123194 | JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 | North American Rescue Products, Inc. | 2013-01-03 | Traditional | PDF ↗ |
| K123035 | SEAL ONE | Perouse Medical | 2012-11-28 | Traditional | PDF ↗ |
| K122405 | AIR-BAND RADIAL COMPRESSION DEVICE | Datascope Corp., Cardiac Assist Division | 2012-11-09 | Traditional | PDF ↗ |
| K120492 | K2 MEDICAL VASCULAR CLAMPS | K2 Medical GmbH & Co. KG | 2012-04-30 | Traditional | PDF ↗ |
| K113600 | IM BAND | Synexmed(Shenzhen)Company Limited | 2012-02-08 | Traditional | PDF ↗ |
| K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP | Medtronic Xomed, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K113182 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | Edwards Lifesciences, LLC | 2011-12-07 | Special | PDF ↗ |
| K112384 | ABDOMINAL TOURNIQUET SYSTEM | Compression Works, LLC | 2011-10-18 | Traditional | PDF ↗ |
| K112694 | EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER | Edwards Lifesciences, LLC | 2011-10-14 | Special | PDF ↗ |
| K111837 | RADIAL ARTERY COMPRESSION TOURNIQUET | Lepu Medical Technology (Beijing) Co., Ltd. | 2011-09-27 | Traditional | PDF ↗ |
| K110148 | WEXLER VASCULAR CLAMP SERIES | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 2011-04-19 | Traditional | PDF ↗ |
| K110193 | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F | St. Jude Medical Systems AB | 2011-02-24 | Special | PDF ↗ |
| K102048 | ATRAUMATIC VASCULAR CLAMPS | Geomed Medizin-Technik GmbH & Co. KG | 2010-11-09 | Traditional | PDF ↗ |
| K102025 | COMBAT READY CLAMP | Combat Medical Systems, LLC | 2010-08-11 | Traditional | PDF ↗ |
| K092503 | RADAR VASCULAR COMPRESSION DEVICES | Advanced Vascular Dynamics | 2009-11-19 | Traditional | PDF ↗ |
| K092544 | INSTRUMED VASCULAR CLAMPS | Instrumed International, Inc. | 2009-10-26 | Traditional | PDF ↗ |
| K090286 | PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE | Advanced Vascular Dynamics | 2009-03-23 | Traditional | PDF ↗ |
| K082930 | CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE | Cardiva Medical, Inc. | 2009-02-13 | Traditional | PDF ↗ |
| K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | Radi Medical Systems AB | 2008-02-26 | Special | PDF ↗ |
| K080169 | HEARTSTRING III PROXIMAL SEAL SYSTEM | Guidant Corporation, Cardiac Surgery | 2008-02-08 | Traditional | PDF ↗ |
| K072834 | SIBEL SA VASCULAR CLAMP | Surgical Instruments Belgium SA | 2008-01-09 | Traditional | PDF ↗ |
| K072297 | BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM | Cardiva Medical, Inc. | 2007-09-12 | Special | PDF ↗ |
| K072167 | COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE | Advanced Vascular Dynamics | 2007-09-06 | Special | PDF ↗ |
| K071225 | INNOVASA STAT*SEAL TOPICAL HEMOSTAT | Innovasa, Inc. | 2007-08-31 | Traditional | PDF ↗ |
| K070661 | VITALCOR FEATHERWEIGHT VASCULAR CLAMPS | Vitalcor, Inc. | 2007-08-29 | Traditional | PDF ↗ |
| K070380 | PORTACLAMP FLEX | Cardio Life Research, S.A. | 2007-06-08 | Traditional | PDF ↗ |
| K070423 | TR BAND | Terumo Medical Corp. | 2007-03-28 | Traditional | PDF ↗ |
| K070485 | BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L | Cardiva Medical, Inc. | 2007-03-22 | Special | PDF ↗ |
| K063871 | D-STAT HANDLE, MODEL 8500-053 | Vascular Solutions, Inc. | 2007-02-28 | Traditional | PDF ↗ |
| K070323 | TEMPORARY LIMB SALVAGE SHUNT | Vascutek, Ltd. | 2007-02-15 | Traditional | PDF ↗ |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | Datascope Corp. | 2007-02-14 | Abbreviated | PDF ↗ |
| K061484 | MODIFICATION TO: SMITHWICK CAROTID SHUNT | Mcpherson Enterprises, Inc. | 2006-12-07 | Special | PDF ↗ |
| K051817 | BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM | Cardiva Medical, Inc. | 2006-12-06 | Traditional | PDF ↗ |
| K062474 | SMITHWICK CAROTID SHUNT | Mcpherson Enterprises, Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K061075 | BOOMERANG WIRE | Cardiva Medical, Inc. | 2006-09-01 | Special | PDF ↗ |
| K053300 | SYVEKEXCEL | Marine Polymer Technologies, Inc. | 2006-03-28 | Traditional | PDF ↗ |
| K053398 | COMPASS COMPRESSION ASSIST HANDLE | Semler Technologies, Inc. Dba | 2006-03-10 | Traditional | PDF ↗ |
| K050146 | VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY | Vascular Solutions, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K041486 | VASOSTASIS VASCULAR CLOSURE SYSTEM | Cardiva Medical, Inc. | 2004-10-22 | Traditional | PDF ↗ |
| K040730 | VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP | Vascular Solutions, Inc. | 2004-06-18 | Traditional | PDF ↗ |
| K040615 | COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM | Advanced Vascular Dynamics | 2004-06-01 | Special | PDF ↗ |
| K033085 | PORTACLAMP | Cardio Life Research, S.A. | 2004-04-27 | Traditional | PDF ↗ |
| K032125 | CSTAT, MODELS 09-0014-01 AND 09-0014-02 | Vascular Control Systems, Inc. | 2004-02-09 | Traditional | PDF ↗ |
| K031812 | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 | Vascular Control Systems, Inc. | 2003-12-12 | Traditional | PDF ↗ |
| K032589 | ENCLOSE II ANASTOMOSIS ASSIST DEVICE | Novare Surgical Systems, Inc. | 2003-09-05 | Special | PDF ↗ |
| K023682 | ENCLOSE ANASTOMOSIS ASSIST DEVICE | Novare Surgical Systems, Inc. | 2003-01-16 | Traditional | PDF ↗ |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | Radi Medical Systems AB | 2002-12-24 | Special | PDF ↗ |
Product code DXC · Class II · Cardiovascular. Data: openFDA.