# K120987: DLP Single Stage Venous Cannula Inflatable Cuff

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jun 6, 2012 after 65 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 K854487 (1986). 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)
- K854487: Venous Return Cannula W/Cuff 91039, Dlp, Inc. (1986) Summary page 1.

## Indications for use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Source page: https://510kreport.com/device/K120987
Methodology: https://510kreport.com/methodology
