# K111187: Patch, Pledget and Intracardiac

- Pathway: 510(k) (Traditional)
- Applicant: Cormatrix Cardiovascular, Inc.
- Decided: Jul 26, 2011 after 90 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). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 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 2.
- K001785: Surgisis Peripheral Vascular Patch, Cook Biotech, Inc. (2000) Summary page 2.
- K983602: CV Peri-Guard and Vascu-Guard, Bio-Vascular, Inc. (1998) Summary page 2.
- K963611: Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch, Vascutek, Ltd. (1996)

## Most influential descendants
- K140789: Cormatrix Ecm for Vascular Repair (2014), 0 descendants of its own

## Indications for use
The CorMatrix® ECM® for Carotid Repair is intended for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture line buttressing.

Source page: https://510kreport.com/device/K111187
Methodology: https://510kreport.com/methodology