510(k) K210681
- Device
- SiteSeal SV
- Applicant
- Ensite Vascular
- 510(k) number
- K210681
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-06
- Date received
- 2021-03-08
- Regulation
- 870.4450
- Classification name
- Clamp, Vascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas Reidy
- Address
- 10900 S. Clay Blair Blvd. Olathe KS US 66061 66061
FDA Registration Numbers#
- 1450019
- 3031571797
- 3010687973
- 3010041511
- 9611112
- 2020550
- 1225991
- 2648612
- 1721676
- 3018312328
- 3031282706
- 2027111
- 1423662
- 3009763019
- 1644312
- 1720747
- 1032347
- 2246552
- 3010202439
- 3006082230
- 3015225571
- 1724474
- 3011642792
- 9612074
- 3032916632
- 3001650535
- 1421879
- 1646747
- 1423537
- 3016733629
- 8030107
- 2126670
- 9610617
- 1721504
- 3042940336
- 9710524
- 3004102031
- 2011171
- 3003418325
- 1118880
- 3015309643
- 1018233
- 9614747
- 3010383847
- 3008500478
- 3011564431
- 3018348
- 1643817
- 3007648354
- 3003761012
- 3007740583
- 8010697
- 3030454941
- 2134812
- 2245304
- 3015151147
- 1226015
- 3006950086
- 2219920
- 8010026
- 3033589330
- 3010707607
- 8010372
- 3006947772
- 3048101437
- 9680837
- 1043214
- 1220351
- 1061927
- 3022815697
- 3006542380
- 3005809810
- 9616088
- 3004111573
- 3005334138
- 3019807891
- 2029275
- 2032098
- 3008258694
- 2648623
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | 2026-07-22 |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | 2026-06-05 |
| 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 |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | Carefusion 2200, Inc. | 2021-03-04 |