Viola
FDA 510(k) K230248 · Vascular Graft Solutions, Ltd.
510(k) numberK230248
Submission
- Device name
- Viola
- Applicant
- Vascular Graft Solutions, Ltd.
Tel Aviv, IL - Received
- January 30, 2023
- Decision date
- February 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | Merit Medical Systems, Inc. | 07/22/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
| K252772 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | Tz Medical, Inc. | 05/22/2026SE |
| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional | Arc Trauma, LLC | 12/31/2025SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K222182 | Radial Artery Compression TourniquetsDXC · Traditional | Beijing Demax Medical Technology Co.,Ltd | 01/04/2023SE |
More from Beijing Demax Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
|---|---|---|
| K203307 | ViolaDXC · Traditional | 02/17/2021SE |
Questions and answers
When was Viola cleared by the FDA?
Viola (K230248) received a 510(k) decision of Substantially Equivalent on February 28, 2023, 29 days after the submission was received.
What is the product code of K230248?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.