Atlas FDA

DXC

205 FDA 510(k) clearances · Product code

94 daysmedian time to decision
272 days90th percentile
205clearances measured

FDA profile

Official device name
Clamp, Vascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 371 · 2022: 273 · 2023: 674 · 2024: 375 · 2025: 449 · 2026: 589
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PreludeSYNC™ Radial Compression Device (K262086)Merit Medical Systems, Inc.2026-07-22
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (K260105)Edwards Lifesciences2026-06-05
Arc Adjustable Radial Cuff Compression Device (K252772)Tz Medical, Inc.2026-05-22
Life Saving Tourniquet (K254060)TW Medical2026-04-03
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (K243627)Arc Trauma, LLC2025-12-31
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) (K253070)Medline Industries, LP2025-11-20
Radial Compression Device (K232577)Ningbo Dizegens Medical Science Co.,Ltd2024-01-18
PICOCLAMP (K230281)Kono Seisakusho Co., Ltd.2023-10-23
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (K221661)Compression Works, Inc.2023-03-03
VIOLA (K230248)Vascular Graft Solutions, Ltd.2023-02-28
Radial Artery Compression Tourniquets (K222182)Beijing Demax Medical Technology Co.,Ltd2023-01-04
GEM Biover Microvascular Clamps (K221843)Synovis Micro Companies Alliance, Inc.2022-09-14
TR BAND Radial Compression Device (K213531)Terumo Medical Corporation2021-12-20
SiteSeal SV (K210681)Ensite Vascular2021-04-06
MI DeTACH (K210006)Biorep Technologies, Inc.2021-03-04
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 (K210324)Carefusion 2200, Inc.2021-03-04
VIOLA (K203307)Vascular Graft Solutions, Ltd.2021-02-17
VASOBand Vascular Compression Device (K203803)Vasoinnovations, Inc.2021-01-26
Patent Hemostasis Band (PH Band) (K201695)Medical Ingenuities2020-10-30
SiteSeal Femoral Compression Device (K192413)Ensite Vacular, LLC2020-03-31
Sunmed Disposable Angio-Closure Pads (K191827)Sunny Medical Device (Shenzhen) Co., Ltd.2020-03-16
Site Seal SV (K190351)Ensite Vascular2019-07-02
VASOBand Vascular Compression Device (K190318)Vasoinnovations, Inc.2019-03-14
PreludeSYNC DISTAL Radial Compression System (K180723)Merit Medical Systems, Inc.2018-04-17
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE (K173563)Tz Medical, Inc.2018-01-10
ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm (K170958)Tricol Biomedical, Inc.2017-08-29
IntraClude Intra-Aortic Occlusion Device (K163693)Edwards Lifesciences, LLC2017-01-26
PreludeSYNC Radial Compression Device (K162988)Merit Medical Systems, Inc.2017-01-25
TRAcelet Compression Device (K162027)Medtronic Vascular2016-10-21
Vein Clamps, Artery Clamps (K161315)Aros Surgical Instruments Corporation2016-08-18
VasoStat Hemostasis Device (K153259)Forge Medical, Inc.2016-01-06
TR BAND Radial Compression Device (K152525)Terumo Medical Corporation2015-11-10
Zephyr Vascular Compression Device (K151363)Advanced Vascular Dynamics2015-07-31
Bookwalter Gordon Adjustable Compression Element (K143078)Symmetry Surgical2015-05-14
iTClamp50 (K150813)Innovative Trauma Care, Inc.2015-04-30
CROC (K141685)Combat Medical Systems, LLC2015-01-26
RADAR VASCULAR COMPRESSION DEVICE (K142122)Advanced Vascular Dynamics2014-12-04
Vasc Band hemostat (K142359)Lepu Medical Technology (Beijing) Co., Ltd.2014-10-23
ITCLAMP 50 (K140805)Innovative Trauma Care, Inc.2014-10-09
SYVEK RADIAL BAND (K132293)Marine Polymer Technologies2014-07-31
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE (K133029)Compression Works, LLC2013-12-06
ITCLAMP 50 (K132651)Innovative Trauma Care, Inc.2013-10-28
COSEAL (K131411)Jilin Coronado Medical , Ltd.2013-09-26
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K132175)Edwards Lifesciences, LLC2013-09-13
CARDIO VISION MICS AORTIC CLAMPS (K123571)Cardiomedical GmbH2013-08-01
SAM JUNCTIONAL TOURNIQUET (K131561)Sam Medical Products2013-07-24
HEARTSTRING III PROXIMAL SEAL SYSTEM (K130382)Boston Scientific Corporation2013-06-05
VASOSTAT HEMOSTASIS DEVICE (K123041)Forge Medical, Inc.2013-05-29
VASCULAR CLAMPS (K123077)Hebumedical GmbH2013-05-14
ITCLAMP 50 (K123551)Innovative Trauma Care, Inc.2013-05-14
COMBAT READY CLAMP (K130482)Combat Medical Systems, LLC2013-04-29
CATALYST II AND III (K130124)Cardiva Medical, Inc.2013-03-14
SAM JUNCTIONAL TOURNIQUET (K123694)Sam Medical Products2013-03-07
JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 (K123194)North American Rescue Products, Inc.2013-01-03
SEAL ONE (K123035)Perouse Medical2012-11-28
AIR-BAND RADIAL COMPRESSION DEVICE (K122405)Datascope Corp., Cardiac Assist Division2012-11-09
K2 MEDICAL VASCULAR CLAMPS (K120492)K2 Medical GmbH & Co. KG2012-04-30
IM BAND (K113600)Synexmed(Shenzhen)Company Limited2012-02-08
MICROFRANCE(R) WORMALD VASCULAR CLAMP (K112662)Medtronic Xomed, Inc.2012-01-20
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K113182)Edwards Lifesciences, LLC2011-12-07
ABDOMINAL TOURNIQUET SYSTEM (K112384)Compression Works, LLC2011-10-18
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER (K112694)Edwards Lifesciences, LLC2011-10-14
RADIAL ARTERY COMPRESSION TOURNIQUET (K111837)Lepu Medical Technology (Beijing) Co., Ltd.2011-09-27
WEXLER VASCULAR CLAMP SERIES (K110148)Microsurgical Laboratories,Inc.Dba Wexler Surgical2011-04-19
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F (K110193)St. Jude Medical Systems AB2011-02-24
ATRAUMATIC VASCULAR CLAMPS (K102048)Geomed Medizin-Technik GmbH & Co. KG2010-11-09
COMBAT READY CLAMP (K102025)Combat Medical Systems, LLC2010-08-11
RADAR VASCULAR COMPRESSION DEVICES (K092503)Advanced Vascular Dynamics2009-11-19
INSTRUMED VASCULAR CLAMPS (K092544)Instrumed International, Inc.2009-10-26
PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE (K090286)Advanced Vascular Dynamics2009-03-23
CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE (K082930)Cardiva Medical, Inc.2009-02-13
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM (K080206)Radi Medical Systems AB2008-02-26
HEARTSTRING III PROXIMAL SEAL SYSTEM (K080169)Guidant Corporation, Cardiac Surgery2008-02-08
SIBEL SA VASCULAR CLAMP (K072834)Surgical Instruments Belgium SA2008-01-09
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM (K072297)Cardiva Medical, Inc.2007-09-12
COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE (K072167)Advanced Vascular Dynamics2007-09-06
INNOVASA STAT*SEAL TOPICAL HEMOSTAT (K071225)Innovasa, Inc.2007-08-31
VITALCOR FEATHERWEIGHT VASCULAR CLAMPS (K070661)Vitalcor, Inc.2007-08-29
PORTACLAMP FLEX (K070380)Cardio Life Research, S.A.2007-06-08
TR BAND (K070423)Terumo Medical Corp.2007-03-28
BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L (K070485)Cardiva Medical, Inc.2007-03-22
D-STAT HANDLE, MODEL 8500-053 (K063871)Vascular Solutions, Inc.2007-02-28
TEMPORARY LIMB SALVAGE SHUNT (K070323)Vascutek, Ltd.2007-02-15
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING (K062569)Datascope Corp.2007-02-14
MODIFICATION TO: SMITHWICK CAROTID SHUNT (K061484)Mcpherson Enterprises, Inc.2006-12-07
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM (K051817)Cardiva Medical, Inc.2006-12-06
SMITHWICK CAROTID SHUNT (K062474)Mcpherson Enterprises, Inc.2006-11-09
BOOMERANG WIRE (K061075)Cardiva Medical, Inc.2006-09-01
SYVEKEXCEL (K053300)Marine Polymer Technologies, Inc.2006-03-28
COMPASS COMPRESSION ASSIST HANDLE (K053398)Semler Technologies, Inc. Dba2006-03-10
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY (K050146)Vascular Solutions, Inc.2005-05-27
VASOSTASIS VASCULAR CLOSURE SYSTEM (K041486)Cardiva Medical, Inc.2004-10-22
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP (K040730)Vascular Solutions, Inc.2004-06-18
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM (K040615)Advanced Vascular Dynamics2004-06-01
PORTACLAMP (K033085)Cardio Life Research, S.A.2004-04-27
CSTAT, MODELS 09-0014-01 AND 09-0014-02 (K032125)Vascular Control Systems, Inc.2004-02-09
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 (K031812)Vascular Control Systems, Inc.2003-12-12
ENCLOSE II ANASTOMOSIS ASSIST DEVICE (K032589)Novare Surgical Systems, Inc.2003-09-05
ENCLOSE ANASTOMOSIS ASSIST DEVICE (K023682)Novare Surgical Systems, Inc.2003-01-16
FEMOSTOP FEMORAL COMPRESSION SYSTEM (K024107)Radi Medical Systems AB2002-12-24
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