510(k) K210324
- Device
- V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
- Applicant
- CareFusion 2200 Inc
- 510(k) number
- K210324
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-04
- Date received
- 2021-02-04
- Regulation
- 870.4450
- Classification name
- Clamp, Vascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jane Weber
- Address
- 75 N Fairway Dr. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 2183620
- 9615817
- 9611112
- 3032916632
- 2245304
- 3006015326
- 8010372
- 1225991
- 1018233
- 3004215117
- 8010591
- 9610617
- 3031571797
- 1060680
- 3007361214
- 2011171
- 1625425
- 1056350
- 1421879
- 1643116
- 3008258694
- 3008002401
- 3005034064
- 3003761012
- 3030454941
- 3010041511
- 9614747
- 1923569
- 3010687973
- 2031768
- 3008729892
- 3022815697
- 3010131137
- 3012536737
- 3004111573
- 3010235355
- 3005687633
- 1054811
- 2030624
- 1724474
- 3033589330
- 3010055973
- 3004102031
- 8010026
- 2015691
- 2320762
- 3009164961
- 3013849323
- 1054241
- 3012507533
- 3010707607
- 1219659
- 3027815
- 3007830707
- 2183744
- 2085887
- 8010697
- 8010871
- 3003675041
- 1032347
- 8010422
- 3005334138
- 3010141307
- 3005593675
- 2027111
- 1450662
- 2024024
- 3023316
- 1836161
- 3012179728
- 3015309643
- 1062741
- 1531062
- 2219920
- 9680515
- 3016704581
- 3004050854
- 9680837
- 1424263
- 1043214
Source Documents#
Other 510(k) Records For Product Code DXC #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases