Cleared Traditional

K221032 - Vascu-Guard Vascular Repair Patch (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221032 · Synovis Life Technologies, Inc. · Cardiovascular device
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Oct 2022
Decision
195d
Days
Class 2
Risk

K221032 is an FDA 510(k) clearance for the Vascu-Guard Vascular Repair Patch. Classified as Intracardiac Patch Or Pledget, Biologically Derived (product code PSQ), Class II - Special Controls.

Submitted by Synovis Life Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 19, 2022 after a review of 195 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Synovis Life Technologies, Inc. devices

Submission Details

510(k) Number K221032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSQ Intracardiac Patch Or Pledget, Biologically Derived
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.