VIOLA

Clamp, Vascular

Vascular Graft Solutions, Ltd.

The following data is part of a premarket notification filed by Vascular Graft Solutions, Ltd. with the FDA for Viola.

Pre-market Notification Details

• Device ID: K203307
• 510k Number: K203307
• Device Name: VIOLA
• Classification: Clamp, Vascular
• Applicant: Vascular Graft Solutions, Ltd. 24 Raoul Wallenberg St Tel-aviv, IL 6971921
• Contact: Orit Yarden
• Correspondent: Janice Hogan; Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103
• Product Code: DXC
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-09
• Decision Date: 2021-02-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290015460873	K203307	000
07290015460866	K203307	000