# K942010: Vascu-Guard

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Jul 7, 1994 after 73 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.
54 later devices descend from it; 6 cite it directly.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 (2004), 17 descendants of its own
- K041736: Pfa Patch (2005), 12 descendants of its own
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), 11 descendants of its own

Source page: https://510kreport.com/device/K942010
Methodology: https://510kreport.com/methodology