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#
- 2126670
- 1032347
- 9710524
- 3010131137
- 8010026
- 3033589330
- 3008258694
- 3007648354
- 3010055973
- 8010168
- 1420032
- 3009164961
- 1118880
- 8040233
- 1416980
- 1220477
- 8010591
- 8010422
- 1054241
- 1421101
- 3005334138
- 3009051888
- 1225598
- 2648612
- 3015225571
- 3007361214
- 2953359
- 3008770252
- 3009142291
- 3006554912
- 1226015
- 1836161
- 3012507533
- 3015151147
- 1644312
- 3009763019
- 1724474
- 2015691
- 3011642792
- 9610612
- 3011564431
- 3007740583
- 9616088
- 1417592
- 2246552
- 3016733629
- 2320762
- 9612074
- 2031768
- 3007074233
- 3003418325
- 3010687973
- 1056350
- 2648045
- 3018348
- 9680515
- 3006542380
- 3005809810
- 3042940336
- 3030454941
- 1531062
- 3027815
- 3032916632
- 1220351
- 9616972
- 2245304
- 2528981
- 3014342096
- 3031282706
- 3012050423
- 3010383847
- 9611112
- 2183620
- 1923569
- 3008998256
- 3006405073
- 3004215117
- 3001650535
- 3012536737
- 3022815697
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#
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