# K031586: Correstore Patch System

- Pathway: 510(k) (Traditional)
- Applicant: Somanetics Corp.
- Decided: Aug 7, 2003 after 78 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: 1 generation back to K011487 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011487: Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS, Somanetics Corp. (2001)

## Indications for use
The CorRestore patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.

Source page: https://510kreport.com/device/K031586
Methodology: https://510kreport.com/methodology