# K974914: Shelhigh NO-React Pericardial Patches

- Pathway: 510(k) (Traditional)
- Applicant: Shelhigh, Inc.
- Decided: Jun 3, 1998 after 177 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 K964467 (1997). 1 ancestor in all.
15 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964467: Shelhigh Pericardial Patch, Shelhigh, Inc. (1997) Summary page 2.

## Most influential descendants
- K982810: Shelhigh NO-React Vascupatch (1998), 12 descendants of its own
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), 11 descendants of its own
- 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

## Indications for use
The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as an intracardiac patch for open heart surgery, as well as to close intercavitary defect, and enlarge the aortic root . The patch may be tailored during surgery to meet the surgeon's needs.

Source page: https://510kreport.com/device/K974914
Methodology: https://510kreport.com/methodology