# K974259: Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences Research Medical
- Decided: Dec 1, 1998 after 383 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 K831769 (1983). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831769: Various Cardiovascular Surgical Device, Research Industries Corp. (1983) Summary page 1.
- K891576: Fem-Flex Femoral Access Cannulation Set, Research Medical, Inc. (1989) Summary page 1.

## Most influential descendants
- K091542: Estech Easyflow Cannula with Guidewire (2009), 1 descendant of its own
- K250610: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (2025), 0 descendants of its own
- K991541: A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 (1999), 0 descendants of its own

## Indications for use
The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended far use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.

Source page: https://510kreport.com/device/K974259
Methodology: https://510kreport.com/methodology