Cleared Special

VIOLA

K230248 · Vascular Graft Solutions, Ltd. · Cardiovascular

Feb 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K230248 is an FDA 510(k) clearance for the VIOLA, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Vascular Graft Solutions, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on February 28, 2023, 29 days after receiving the submission on January 30, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K230248 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2023
Decision Date	February 28, 2023
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF