# K963368: Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible

- Pathway: 510(k) (Traditional)
- Applicant: Glycar, Inc.
- Decided: Oct 31, 1997 after 430 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 K942010 (1994). 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)
- K942010: Vascu-Guard, Bio-Vascular, Inc. (1994) Summary page 1.

## Indications for use
The Glycar Pericardial Patch and Glycar Vascular Patch of the Glycar Tissue Repair Patch line of products are intended for pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.

Source page: https://510kreport.com/device/K963368
Methodology: https://510kreport.com/methodology