# K963967: Glycar Pericardial Patch

- Pathway: 510(k) (Traditional)
- Applicant: Glycar, Inc.
- Decided: Oct 31, 1997 after 394 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923657 (1992). 1 ancestor in all.
20 later devices descend from it; 3 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.

## Most influential descendants
- K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 (2004), 17 descendants of its own
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own
- K082139: Edwards Bovine Pericardial Patch, Model 4700 (2008), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own

## Recalls of this device
- Oct 9, 2025 · Class I · Z-0532-2026: The impacted lot may not meet the required tensile strength specification.
- Oct 9, 2025 · Class I · Z-0531-2026: The impacted lot may not meet the required tensile strength specification.

## 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/K963967
Methodology: https://510kreport.com/methodology