# K081438: Matracell Decellularized Pulmonary Artery Patch Allograft

- Pathway: 510(k) (Traditional)
- Applicant: Lifenet Health
- Decided: Oct 17, 2008 after 148 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: 6 generations back to K921895 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993288: Sulzer Carbomedics Cardiofix Pericardium, Sulzer Carbomedics, Inc. (1999) Summary page 1.
- K063349: Cormatrix Patch for Cardiac Tissue Repair, Cormatrix Cardiovascular, Inc. (2007) Summary page 1.

## Indications for use
The MatrACELL TM Decellularized Pulmonary Artery Patch Allograft is indicated for repair of the right ventricular outflow tract.

Source page: https://510kreport.com/device/K081438
Methodology: https://510kreport.com/methodology