# Shelhigh, Inc.

- Location (FDA's records): Millburn, NJ
- FDA decisions: 8 (1997–2003): 8 510(k) clearances
- Product codes: DXZ (3), FTL (2), FTM (1), GXQ (1), KRH (1)
- Predicates its devices cite: 8 (6 its own); citations of its devices by later devices: 7 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Vascular, Inc.: 1 (https://510kreport.com/company/bio-vascular)
- Meadox Medicals, Div. Boston Scientific Corp.: 1 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)

## Firms that cite its devices most
- Cormatrix Cardiovascular, Inc.: 1 (https://510kreport.com/company/cormatrix-cardiovascular)

## Its most-cited devices
- K974914: Shelhigh NO-React Pericardial Patches (1998), cited by 3
- K964467: Shelhigh Pericardial Patch (1997), cited by 2
- K981756: Shelhigh NO-React Pneumopledgets (1998), cited by 1
- K982810: Shelhigh NO-React Vascupatch (1998), cited by 1

## Recent decisions
- K032893: Shelhigh NO-React Biocuff (Dec 19, 2003)
- K023940: Shelhigh Bioring (Jun 4, 2003)
- K982101: Shelhigh NO-React Dura Shield (May 2, 2000)
- K991567: Shelhigh NO-React Tissue Repair Patch/Uropatch. (Jul 14, 1999)
- K982810: Shelhigh NO-React Vascupatch (Oct 28, 1998)
- K981756: Shelhigh NO-React Pneumopledgets (Aug 5, 1998)
- K974914: Shelhigh NO-React Pericardial Patches (Jun 3, 1998)
- K964467: Shelhigh Pericardial Patch (Sep 23, 1997)

Source page: https://510kreport.com/company/shelhigh