# K961181: Nmi Vein Graft Perfusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Naltiac Medical, Inc.
- Decided: Jun 21, 1996 after 87 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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 K791498 (1979). 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)
- K791498: Adapter-Y Type/Coronary Perfusion, Dlp, Inc. (1979) Summary page 1.

## Indications for use
The NMI Vein Graft Perfusion Set is intended to be used during a cardiopulmonary bypass procedure to connect multiple coronary cannulae to a single infusion line.

Source page: https://510kreport.com/device/K961181
Methodology: https://510kreport.com/methodology