DXC · Class II · 21 CFR 870.4450

FDA Product Code DXC: Clamp, Vascular

Leading manufacturers include Edwards Lifesciences, LLC, Allegiance Healthcare Corp. and Vascular Solutions, Inc..

205
Total
205
Cleared
132d
Avg days
1976
Since
Stable submission activity - 6 submissions in the last 2 years
Review times increasing: avg 167d recently vs 131d historically

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

205 devices
1–24 of 205
Cleared Jul 22, 2026
PreludeSYNC™ Radial Compression Device
K262086
Merit Medical Systems, Inc.
Cardiovascular · 30d
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

About Product Code DXC - Regulatory Context

510(k) Submission Activity

205 total 510(k) submissions under product code DXC since 1976, with 205 receiving FDA clearance (average review time: 132 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - DXC Product Code

Recent submissions under DXC have taken an average of 167 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 →