# K964467: Shelhigh Pericardial Patch

- Pathway: 510(k) (Traditional)
- Applicant: Shelhigh, Inc.
- Decided: Sep 23, 1997 after 320 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
No predicates in its family tree.
16 later devices descend from it; 2 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K974914: Shelhigh NO-React Pericardial Patches (1998), 15 descendants of its own
- 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

## Indications for use
The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.

Source page: https://510kreport.com/device/K964467
Methodology: https://510kreport.com/methodology