Cleared Traditional

Vascu-Guard Vascular Repair Patch

K221032 · Synovis Life Technologies, Inc. · Cardiovascular

Oct 2022

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K221032 is an FDA 510(k) clearance for the Vascu-Guard Vascular Repair Patch, a Intracardiac Patch Or Pledget, Biologically Derived (Class II — Special Controls, product code PSQ), submitted by Synovis Life Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 19, 2022, 195 days after receiving the submission on April 7, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K221032 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2022
Decision Date	October 19, 2022
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PSQ — Intracardiac Patch Or Pledget, Biologically Derived
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.3470
Definition	To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.