DXC · Class II · 21 CFR 870.4450

FDA Product Code DXC: Clamp, Vascular

Leading manufacturers include Merit Medical Systems, Inc., Tz Medical, Inc. and Vasoinnovations, Inc..

204
Total
204
Cleared
133d
Avg days
1976
Since
Stable submission activity - 5 submissions in the last 2 years
Review times increasing: avg 194d recently vs 131d historically

FDA 510(k) Cleared Clamp, Vascular Devices (Product Code DXC)

204 devices
1–24 of 204
Cleared Jun 05, 2026
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
K260105
Edwards Lifesciences
Cardiovascular · 143d
Cleared May 22, 2026
Arc Adjustable Radial Cuff Compression Device
K252772
Tz Medical, Inc.
Cardiovascular · 262d
Cleared Apr 03, 2026
Life Saving Tourniquet
K254060
TW Medical
Cardiovascular · 107d
Cleared Dec 31, 2025
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC)
K243627
Arc Trauma, LLC
Cardiovascular · 401d
Cleared Nov 20, 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070
Medline Industries, LP
Cardiovascular · 58d
Cleared Jan 18, 2024
Radial Compression Device
K232577
Ningbo Dizegens Medical Science Co.,Ltd
Cardiovascular · 146d
Cleared Oct 23, 2023
PICOCLAMP
K230281
Kono Seisakusho Co., Ltd.
Cardiovascular · 264d
Cleared Mar 03, 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661
Compression Works, Inc.
Cardiovascular · 268d
Cleared Feb 28, 2023
VIOLA
K230248
Vascular Graft Solutions, Ltd.
Cardiovascular · 29d
Cleared Jan 04, 2023
Radial Artery Compression Tourniquets
K222182
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 166d
Cleared Sep 14, 2022
GEM Biover Microvascular Clamps
K221843
Synovis Micro Companies Alliance, Inc.
Cardiovascular · 82d
Cleared Dec 20, 2021
TR BAND Radial Compression Device
K213531
Terumo Medical Corporation
Cardiovascular · 45d
Cleared Apr 06, 2021
SiteSeal SV
K210681
Ensite Vascular
Cardiovascular · 29d
Cleared Mar 04, 2021
MI DeTACH
K210006
Biorep Technologies, Inc.
Cardiovascular · 59d
Cleared Mar 04, 2021
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
K210324
Carefusion 2200, Inc.
Cardiovascular · 28d
Cleared Feb 17, 2021
VIOLA
K203307
Vascular Graft Solutions, Ltd.
Cardiovascular · 100d
Cleared Jan 26, 2021
VASOBand Vascular Compression Device
K203803
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Oct 30, 2020
Patent Hemostasis Band (PH Band)
K201695
Medical Ingenuities
Cardiovascular · 130d
Cleared Mar 31, 2020
SiteSeal Femoral Compression Device
K192413
Ensite Vacular, LLC
Cardiovascular · 209d
Cleared Mar 16, 2020
Sunmed Disposable Angio-Closure Pads
K191827
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular · 252d
Cleared Jul 02, 2019
Site Seal SV
K190351
Ensite Vascular
Cardiovascular · 138d
Cleared Mar 14, 2019
VASOBand Vascular Compression Device
K190318
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Apr 17, 2018
PreludeSYNC DISTAL Radial Compression System
K180723
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Jan 10, 2018
ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
K173563
Tz Medical, Inc.
Cardiovascular · 54d

About Product Code DXC - Regulatory Context

510(k) Submission Activity

204 total 510(k) submissions under product code DXC since 1976, with 204 receiving FDA clearance (average review time: 133 days).

Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.

FDA 510(k) Review Time - DXC Product Code

Recent submissions under DXC have taken an average of 194 days to reach a decision - up from 131 days historically. Manufacturers should account for longer review timelines in current project planning.

DXC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →