# K250283: RAP Femoral Venous Cannulae

- Pathway: 510(k) (Special)
- Applicant: LivaNova USA, Inc.
- Decided: Jul 10, 2025 after 160 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: 3 generations back to K845045 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula, Estech, Inc. (2005) Summary page 6.

## Indications for use
The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

Source page: https://510kreport.com/device/K250283
Methodology: https://510kreport.com/methodology