# K971726: CV Peri-Guard - Cardiovascular Patch

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Apr 10, 1998 after 336 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 4 cite it directly.
2 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gore-Tex Cardiovascular Patch: named in the summary without a submission number
- (no number) Peri-Guard: named in the summary without a submission number
- (no number) Vascu-Guard: named in the summary without a submission number

## Most influential descendants
- K983602: CV Peri-Guard and Vascu-Guard (1998), 31 descendants of its own
- 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
- K082139: Edwards Bovine Pericardial Patch, Model 4700 (2008), 5 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own

## 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.

Source page: https://510kreport.com/device/K971726
Methodology: https://510kreport.com/methodology