# K992776: Uni-Graft K DV Patch

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Nov 16, 1999 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
A vascular patch used for reconstructive interventions in the region of the carotid artery, profunda, femoral, arteria iliaca.

Source page: https://510kreport.com/device/K992776
Methodology: https://510kreport.com/methodology