# K063349: Cormatrix Patch for Cardiac Tissue Repair

- Pathway: 510(k) (Traditional)
- Applicant: Cormatrix Cardiovascular, Inc.
- Decided: Feb 16, 2007 after 102 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: 5 generations back to K921895 (1992). 24 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 2.
- K051405: Regensis Pericardial Patch, Cormatrix Cardiovascular, Inc. (2005) Summary page 2.
- K041736: Pfa Patch, Peritec Biosciences, LLC (2005) Summary page 2.
- K982810: Shelhigh NO-React Vascupatch, Shelhigh, Inc. (1998) Summary page 2.
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 2.
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement, Synovis Surgical Innovations (2004) Summary page 2.
- K041716: Ptfe Felts and Pledgets, Boston Scientific Corp (2004) Summary page 2.

## Most influential descendants
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), 3 descendants of its own
- K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (2018), 2 descendants of its own
- K152127: CorMatrix Tyke (2016), 2 descendants of its own
- K192616: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (2019), 1 descendant of its own

## Indications for use
The CorMatrix® Patch for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair (i.e., arterial septal defect (ASD), ventricular septal defect (VSD), etc.) and suture-line buttressing.

Source page: https://510kreport.com/device/K063349
Methodology: https://510kreport.com/methodology