510(k) K203307
- Device
- VIOLA
- Applicant
- Vascular Graft Solutions, Ltd.
- 510(k) number
- K203307
- Product code
- DXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-17
- Date received
- 2020-11-09
- 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
- Orit Yarden
- Address
- 24 Raoul Wallenberg St. Tel Aviv IL 6971921 6971921
FDA Registration Numbers#
- 3030078769
- 3012050423
- 1423537
- 3008998256
- 2029275
- 2024024
- 1643116
- 1056553
- 2528981
- 9610612
- 2242352
- 3031282706
- 3004102031
- 9680837
- 3032534
- 3011642792
- 1423662
- 3006947772
- 1625519
- 3005593675
- 1118880
- 1625425
- 3009142291
- 3009265194
- 3005809810
- 3009810261
- 2648623
- 3007830707
- 3010202439
- 9616088
- 1450019
- 2011171
- 1421101
- 1018233
- 3001650535
- 3004608878
- 1054241
- 8010422
- 1225991
- 2245304
- 3022815697
- 3007014520
- 3010601992
- 3031571797
- 1032347
- 8010372
- 1927395
- 3008729892
- 9710524
- 3018312328
- 3008717566
- 3020031299
- 1220477
- 1923569
- 3003761012
- 2219920
- 3010055973
- 9611112
- 3008002401
- 9611484
- 3010652124
- 1055236
- 1016427
- 1720747
- 3004111573
- 9616972
- 3033536312
- 1061927
- 3015547863
- 1644312
- 3021140368
- 3009164961
- 2953359
- 3008500478
- 3010141307
- 3032916632
- 2126670
- 3038185753
- 2134812
- 1643817
Source Documents#
Other 510(k) Records For Product Code DXC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K203803 | VASOBand Vascular Compression Device | Vasoinnovations, Inc. | 2021-01-26 |
Legacy Summary#
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
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