# K031948: Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

- Pathway: 510(k) (Traditional)
- Applicant: Pm Devices, Inc.
- Decided: Sep 16, 2003 after 84 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.
36 later devices descend from it; 3 cite it directly.
0 of 37 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
- K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 (2004), 17 descendants of its own
- K051405: Regensis Pericardial Patch (2005), 15 descendants of its own
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), 11 descendants of its own
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own

## Indications for use
The PeriPatch Sheet is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair.

Source page: https://510kreport.com/device/K031948
Methodology: https://510kreport.com/methodology