# K842066: Peri-Guard Pericardial Patch

- Pathway: 510(k) (Traditional)
- Applicant: Genetic Laboratories, Inc.
- Decided: Dec 30, 1985 after 616 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.
340 later devices descend from it; 4 cite it directly.
1 of 341 devices in its family (counting itself) has 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
- K961811: Peri-Guard Pericardium (1996), 339 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
- 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

Source page: https://510kreport.com/device/K842066
Methodology: https://510kreport.com/methodology