# K921895: Tissue Patch, Tissue Graft

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Nov 4, 1992 after 196 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.
410 later devices descend from it; 7 cite it directly.
2 of 411 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K961810: Supple Peri-Guard Pericardium (1996), 409 descendants of its own
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc (1998), 336 descendants of its own
- K980431: Surgisis (1998), 284 descendants of its own
- K992159: Surgisis Sling (1999), 204 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own

## Indications for use
Supple Peri-Guard is intended for use during cardiac surgical procedures as a patch for closure of the patient's pericardium. The patch may be tailored during surgery to meet the surgeon's needs.

Source page: https://510kreport.com/device/K921895
Methodology: https://510kreport.com/methodology