# K210331: CardiaMend Pericardial and Epicardial Reconstruction Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Helios Cardio, Inc.
- Decided: Dec 21, 2021 after 319 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: 8 generations back to K921895 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181038: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack), Cormatrix Cardiovascular, Inc. (2018) Summary page 4.
- K051405: Regensis Pericardial Patch, Cormatrix Cardiovascular, Inc. (2005) Summary page 4.

## Indications for use
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.

Source page: https://510kreport.com/device/K210331
Methodology: https://510kreport.com/methodology