# K221029: PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Life Technologies, Inc.
- Decided: Oct 19, 2022 after 195 days
- Product code: PSQ (Intracardiac Patch Or Pledget, Biologically Derived)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K842066 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142447: PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch, Synovis Life Technologies, Inc. (2015) Summary page 4.
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 4.

## Recalls of this device
- Dec 6, 2023 · Class II · Z-0664-2024: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for

## Indications for use
PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing. SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

Source page: https://510kreport.com/device/K221029
Methodology: https://510kreport.com/methodology