# K961180: Nmi Antegrad Cardioplegia Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Naltiac Medical, Inc.
- Decided: Jun 21, 1996 after 87 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 K790565 (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)
- K790565: Aortic Root Cannula, Dlp, Inc. (1979) Summary page 1.

## Indications for use
The NMI Antegrade Cardioplegia Cannulae are intended to be used to deliver cardioplegia solutions to the heart or venting cardioplegia away from the heart via the ascending aorta. The cannulae may also be use to aspirate air from the ascending aorta.

Source page: https://510kreport.com/device/K961180
Methodology: https://510kreport.com/methodology