# K142461: VASCU-GUARD Peripheral Vascular Patch

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Life Technologies, Inc.
- Decided: Nov 25, 2014 after 84 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921895 (1992). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 4.

## Most influential descendants
- K221032: Vascu-Guard Vascular Repair Patch (2022), 0 descendants of its own

## Recalls of this device
- May 2, 2015 · Class I · Z-1637-2015: Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.

## Indications for use
VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

Source page: https://510kreport.com/device/K142461
Methodology: https://510kreport.com/methodology