510(k) K253070
- Device
- Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
- Applicant
- Medline Industries, LP
- 510(k) number
- K253070
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-20
- Date received
- 2025-09-23
- 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
- N
Applicant Contact#
- Contact
- Payal Solanki
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers#
- 3010055973
- 3010131137
- 3006950086
- 9616088
- 3005593675
- 3012179728
- 1625519
- 3016704581
- 2648045
- 3017056829
- 3006947772
- 1032347
- 1927395
- 3033589330
- 3010601992
- 3032916632
- 3011564431
- 2528981
- 3005809810
- 1721676
- 1720929
- 1424263
- 9611484
- 3022815697
- 2020550
- 3033536312
- 3011137372
- 3010707607
- 9616972
- 3010202439
- 3001650535
- 3012050423
- 3016096142
- 9611112
- 3007014520
- 3009142291
- 1056553
- 8010026
- 9610617
- 2011171
- 8030107
- 2027111
- 3003675041
- 3009810261
- 1054811
- 3004050854
- 1016427
- 1416980
- 8010422
- 1220477
- 1417592
- 1226015
- 9681834
- 2245304
- 1225991
- 3008864603
- 3031571797
- 1720747
- 3010235355
- 2085887
- 1060680
- 9680837
- 8010697
- 1522875
- 3008717566
- 1423662
- 1721504
- 1643116
- 1724474
- 9615817
- 9680519
- 1018233
- 1220351
- 1450662
- 3005687633
- 3011642792
- 3004215117
- 3010041511
- 3018312328
- 2126670
Source Documents#
Other 510(k) Records For Product Code DXC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | Carefusion 2200, Inc. | 2021-03-04 |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021-03-04 |
| K203307 | VIOLA | Vascular Graft Solutions, Ltd. | 2021-02-17 |