# K250937: Venous Return Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: LivaNova USA, Inc.
- Decided: Mar 11, 2026 after 348 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: 7 generations back to K840002 (1984). 81 ancestors in all.
No later device cites it as a predicate yet.
1 of 82 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943934: Aortic Arch Cannulas, Sorin Group Italia S.R.L. (1995) Summary page 5.
- K890980: Modified Stockert-Shiley Venous Catheter, Shiley, Inc. (1989) Summary page 5.
- K861496: Stockert-Shiley Venous Cath & Aortic Arch Cannula, Shiley, Inc. (1986) Summary page 6.
- K994209: Stockert V142 Series Venous Cannulae with Lighthouse Tip, Cobe Cardiovascular, Inc. (2000) Summary page 6.
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right, Medtronic, Inc. (2012) Summary page 6.

## Indications for use
The Venous Return Cannula is indicated for use in drainage of the superior and inferior vena cava during cardiopulmonary bypass surgery for up to six hours.

Source page: https://510kreport.com/device/K250937
Methodology: https://510kreport.com/methodology