# K221032: Vascu-Guard Vascular 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 K921895 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142461: VASCU-GUARD Peripheral Vascular Patch, Synovis Life Technologies, Inc. (2014) 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-0666-2024: 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
VASCU‑GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous access revisions.

Source page: https://510kreport.com/device/K221032
Methodology: https://510kreport.com/methodology