# K891576: Fem-Flex Femoral Access Cannulation Set

- Pathway: 510(k) (Traditional)
- Applicant: Research Medical, Inc.
- Decided: Oct 12, 1989 after 206 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 6 cite it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052081: Remote Access Perfusion (Rap) Femoral Venous Cannula (2005), 8 descendants of its own
- K060101: Estech Aortic Easy Flow Cannula (2006), 6 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K974259: Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae (1998), 3 descendants of its own
- K123303: Femoral Access Venous Cannulae (2013), 2 descendants of its own

## Recalls of this device
- Feb 25, 2008 · Not classified · Z-1894-2008: Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass
- Feb 25, 2008 · Not classified · Z-1893-2008: Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass

Source page: https://510kreport.com/device/K891576
Methodology: https://510kreport.com/methodology