# K140789: Cormatrix Ecm for Vascular Repair

- Pathway: 510(k) (Traditional)
- Applicant: Cormatrix Cardiovascular, Inc.
- Decided: Jul 15, 2014 after 106 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: 7 generations back to K921895 (1992). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 1.
- K111187: Patch, Pledget and Intracardiac, Cormatrix Cardiovascular, Inc. (2011) Summary page 1.
- K001785: Surgisis Peripheral Vascular Patch, Cook Biotech, Inc. (2000) Summary page 1.
- K063349: Cormatrix Patch for Cardiac Tissue Repair, Cormatrix Cardiovascular, Inc. (2007) Summary page 1.

## Indications for use
The CorMatrix ECM for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

Source page: https://510kreport.com/device/K140789
Methodology: https://510kreport.com/methodology