# K082139: Edwards Bovine Pericardial Patch, Model 4700

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 23, 2008 after 86 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
Longest line of descent: 4 generations back to K842066 (1985). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833763: Pericardial Patch, American Edwards Laboratories (1984) Summary page 1.
- K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16, Pm Devices, Inc. (2004) Summary page 1.
- K971726: CV Peri-Guard - Cardiovascular Patch, Bio-Vascular, Inc. (1998) Summary page 1.
- K963967: Glycar Pericardial Patch, Glycar, Inc. (1997) Summary page 1.
- K942010: Vascu-Guard, Bio-Vascular, Inc. (1994) Summary page 1.

## Most influential descendants
- K130872: Cardiocel (2014), 3 descendants of its own
- K162579: VascuCel (2016), 1 descendant of its own
- K200566: ADAPT Tissue (2020), 0 descendants of its own
- K172660: Duravess bovine pericardial vascular patch (2017), 0 descendants of its own
- K170951: CardioCel 3D (2017), 0 descendants of its own

## Indications for use
The pericardial patch is intended for use as a surgical patch material for: augmenting the patient's own pericardium to assist in closure following open-heart surgery; intracardiac defects; septal defects and annulus repairs; cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; great vessel reconstruction and repairs; and suture-line buttressing.

Source page: https://510kreport.com/device/K082139
Methodology: https://510kreport.com/methodology