# K961811: Peri-Guard Pericardium

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Jun 13, 1996 after 34 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842066 (1985). 2 ancestors in all.
339 later devices descend from it; 3 cite it directly.
1 of 342 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842066: Peri-Guard Pericardial Patch, Genetic Laboratories, Inc. (1985) Summary page 1.
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.

## Most influential descendants
- 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
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K992537: Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated (2000), 147 descendants of its own
- K014183: Afb (Absorbable Foam Buttress) (2002), 145 descendants of its own
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 143 descendants of its own

## Indications for use
Peri-Guard is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hemias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Source page: https://510kreport.com/device/K961811
Methodology: https://510kreport.com/methodology