510(k) K123035
- Device
- SEAL ONE
- Applicant
- Perouse Medical
- 510(k) number
- K123035
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-11-28
- Date received
- 2012-09-28
- Regulation
- 870.4450
- Classification name
- Clamp, Vascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROLINE DAURELLE
- Address
- 135 Rte. Neuve Irigny FR 69540 69540
FDA Registration Numbers#
- 3008998256
- 1225598
- 3007648354
- 9616972
- 8040233
- 1416980
- 2031768
- 2020550
- 9610612
- 1720747
- 3003418325
- 8010026
- 3008770252
- 2219920
- 1056350
- 1724474
- 1420032
- 1720929
- 1643817
- 3008500478
- 3038185753
- 1417592
- 3012507533
- 3009763019
- 3042940336
- 1055236
- 1423537
- 3009051888
- 8010591
- 3007830707
- 1032347
- 3030078769
- 3004050854
- 1646747
- 3030454941
- 3008002401
- 9680515
- 9681834
- 2032098
- 1018233
- 3008729892
- 1060680
- 3017056829
- 3021140368
- 3023316
- 3013849323
- 9680519
- 3008864603
- 2183744
- 2126670
- 2648623
- 8010303
- 3007361214
- 3011137372
- 1220351
- 9612074
- 3006950086
- 9614747
- 3004111573
- 3005528784
- 1836161
- 8030107
- 3006947772
- 2245304
- 3032534
- 3011564431
- 1056553
- 3005334138
- 1016427
- 3012995405
- 3031571797
- 1054241
- 3007740583
- 3033589330
- 3009265194
- 3032916632
- 3012050423
- 8010871
- 1118880
Source Documents#
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 |
| K210681 | SiteSeal SV | Ensite Vascular | 2021-04-06 |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 |
Legacy Summary#
summary
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