# K191734: MatriStem UBM Pericardial Patch

- Pathway: 510(k) (Traditional)
- Applicant: Acell, Inc.
- Decided: Nov 22, 2019 after 147 days
- Product code: PSQ (Intracardiac Patch Or Pledget, Biologically Derived)
- 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: 5 generations back to K921895 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051405: Regensis Pericardial Patch, Cormatrix Cardiovascular, Inc. (2005) Summary page 4.

## Indications for use
The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.

Source page: https://510kreport.com/device/K191734
Methodology: https://510kreport.com/methodology