# K152127: CorMatrix Tyke

- Pathway: 510(k) (Traditional)
- Applicant: Cormatrix Cardiovascular, Inc.
- Decided: Feb 4, 2016 after 188 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). 25 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063349: Cormatrix Patch for Cardiac Tissue Repair, Cormatrix Cardiovascular, Inc. (2007) Summary page 4.

## Most influential descendants
- 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) (2018), 1 descendant of its own
- K210331: CardiaMend Pericardial and Epicardial Reconstruction Matrix (2021), 0 descendants of its own

## Indications for use
The CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.

Source page: https://510kreport.com/device/K152127
Methodology: https://510kreport.com/methodology