510(k) K123551
- Device
- ITCLAMP 50
- Applicant
- INNOVATIVE TRAUMA CARE INC
- 510(k) number
- K123551
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-14
- Date received
- 2012-11-19
- 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
- RICHARD WAITE
- Address
- 3463 Magic Dr., Suite 120 San Antonio TX US 78229 78229
FDA Registration Numbers#
- 1417592
- 8030107
- 3032534
- 1225991
- 3012050423
- 3005334138
- 3007361214
- 8010422
- 2029275
- 3004111573
- 3010041511
- 9616972
- 1644312
- 9680515
- 3006405073
- 2648623
- 3010652124
- 1531062
- 1062741
- 1416980
- 3012995405
- 1643817
- 1836161
- 3007074233
- 3022815697
- 9611484
- 1319660
- 1056350
- 1450662
- 3015309643
- 3010235355
- 3033536312
- 9710524
- 3005593675
- 3005687633
- 2032098
- 3027815
- 3009164961
- 3016096142
- 3005034064
- 8010697
- 3012179728
- 3010202439
- 3015547863
- 3001650535
- 1018233
- 9610612
- 1646747
- 3005528784
- 3033589330
- 3014342096
- 2024024
- 3013849323
- 3015225571
- 1225598
- 1724474
- 8010871
- 9680519
- 9616088
- 9612086
- 3038185753
- 9614747
- 3010141307
- 3011642792
- 8010168
- 3011137372
- 3018312328
- 3030078769
- 3010687973
- 1016427
- 8040233
- 1118880
- 1032347
- 3012536737
- 2916714
- 9615817
- 2183620
- 2242352
- 3010383847
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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