Product code DXC
- Device name
- Clamp, Vascular
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4450
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | 2026-05-22 |
| K254060 | Life Saving Tourniquet | TW Medical | 2026-04-03 |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC | 2025-12-31 |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Medline Industries, LP | 2025-11-20 |
| K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | 2024-01-18 |
| K230281 | PICOCLAMP | Kono Seisakusho Co., Ltd. | 2023-10-23 |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Compression Works, Inc. | 2023-03-03 |
| K230248 | VIOLA | Vascular Graft Solutions, Ltd. | 2023-02-28 |
| K222182 | Radial Artery Compression Tourniquets | Beijing Demax Medical Technology Co.,Ltd | 2023-01-04 |
| K221843 | GEM Biover Microvascular Clamps | Synovis Micro Companies Alliance, Inc. | 2022-09-14 |
| K213531 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2021-12-20 |
| K210681 | SiteSeal SV | Ensite Vascular | 2021-04-06 |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | Carefusion 2200, Inc. | 2021-03-04 |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 |
| K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021-02-17 |
| K203803 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2021-01-26 |
| K201695 | Patent Hemostasis Band (PH Band) | Medical Ingenuities | 2020-10-30 |
| K192413 | SiteSeal Femoral Compression Device | Ensite Vacular, LLC | 2020-03-31 |
| K191827 | Sunmed Disposable Angio-Closure Pads | Sunny Medical Device (Shenzhen) Co., Ltd. | 2020-03-16 |
| K190351 | Site Seal SV | Ensite Vascular | 2019-07-02 |
| K190318 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2019-03-14 |
| K180723 | PreludeSYNC DISTAL Radial Compression System | Merit Medical Systems, Inc. | 2018-04-17 |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | Tz Medical, Inc. | 2018-01-10 |
| K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | Tricol Biomedical, Inc. | 2017-08-29 |
| K163693 | IntraClude Intra-Aortic Occlusion Device | Edwards Lifesciences, LLC | 2017-01-26 |
| K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017-01-25 |
| K162027 | TRAcelet Compression Device | Medtronic Vascular | 2016-10-21 |
| K161315 | Vein Clamps, Artery Clamps | Aros Surgical Instruments Corporation | 2016-08-18 |
| K153259 | VasoStat Hemostasis Device | Forge Medical, Inc. | 2016-01-06 |
| K152525 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2015-11-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20197344138897 | NAMIC | MEDLINE INDUSTRIES, INC. | 2026-03-16 |
| 00192896122727 | Debakey Coarctation Clamp | SONTEC INSTRUMENTS, INC. | 2026-03-10 |
| 00192896122710 | Debakey Coarctation Clamp | SONTEC INSTRUMENTS, INC. | 2026-03-10 |
| 00192896122697 | Cooley Vascular Clamp | SONTEC INSTRUMENTS, INC. | 2026-03-10 |
| 00884450846032 | Safeguard Radial™ | Merit Medical Systems, Inc. | 2026-02-20 |
| 00840479401027 | enableCV IntraClude™ Intra-Aortic Occlusion Device | ENABLECV INC. | 2026-02-06 |
| 08022057015945 | DeTACH Aortic Cross Clamp Delivery Device | CORCYM SRL | 2026-02-03 |
| 08022057015921 | DeTACH Aortic Cross Clamp Quick Release Device | CORCYM SRL | 2026-02-03 |
| 08022057015914 | DeTACH Aortic Cross Clamp Delivery System | CORCYM SRL | 2026-02-03 |
| 18022057015904 | DeTACH Aortic Cross Clamp Head-Small | CORCYM SRL | 2026-02-03 |
| 08022057015891 | DeTACH Aortic Cross Clamp Head- Medium | CORCYM SRL | 2026-02-03 |
| 18022057015881 | DeTACH Aortic Cross Clamp Head-Large | CORCYM SRL | 2026-02-03 |
| 00810123209507 | Adler Instrument Company | Adler, Inc. | 2025-08-19 |
| 00810123209514 | Adler Instrument Company | Adler, Inc. | 2025-08-19 |
| 00810123209521 | Adler Instrument Company | Adler, Inc. | 2025-08-19 |
| 00810123209538 | Adler Instrument Company | Adler, Inc. | 2025-08-19 |
| 24026704736243 | PILLING | TELEFLEX INCORPORATED | 2020-11-16 |
| 07640174510160 | Biover | Biover AG | 2016-09-27 |
| 07640174510269 | Biover | Biover AG | 2016-09-27 |
| 07640174510207 | Biover | Biover AG | 2016-09-27 |
| 07640174510047 | Biover | Biover AG | 2016-09-27 |
| 07640174510023 | Biover | Biover AG | 2016-09-27 |
| 20884521152066 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 20884521152134 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 20884521152127 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 20884521152110 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 20884521152103 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 20884521152097 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 20884521152080 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 20884521152073 | Devon | Cardinal Health, Inc. | 2016-09-24 |