# K983602: CV Peri-Guard and Vascu-Guard

- Pathway: 510(k) (Special)
- Applicant: Bio-Vascular, Inc.
- Decided: Nov 12, 1998 after 30 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921895 (1992). 5 ancestors in all.
31 later devices descend from it; 10 cite it directly.
2 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971726: CV Peri-Guard - Cardiovascular Patch, Bio-Vascular, Inc. (1998) Summary page 1.
- K942010: Vascu-Guard, Bio-Vascular, Inc. (1994) Summary page 2.
- K961810: Supple Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 3.
- K921895: Tissue Patch, Tissue Graft, Bio-Vascular, Inc. (1992) Summary page 3.

## Most influential descendants
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement (2004), 24 descendants of its own
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), 11 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own
- K041669: Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD (2004), 4 descendants of its own
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), 3 descendants of its own

## Recalls of this device
- Dec 6, 2023 · Class II · Z-0669-2024: 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
- Jun 24, 2016 · Class II · Z-2533-2016: Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperative bleeding 
- Oct 28, 2013 · Class II · Z-0338-2014: Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipmen

## Indications for use
CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing. Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions. Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hemias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Source page: https://510kreport.com/device/K983602
Methodology: https://510kreport.com/methodology