# K123298: Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Mar 15, 2013 after 143 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891576 (1989). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891576: Fem-Flex Femoral Access Cannulation Set, Research Medical, Inc. (1989) Summary page 1.
- K905312: Duraflo II Heparin Treated Femoral Cannulae Models, Baxter Bentley Laboratories, Inc. (1991) Summary page 1.
- K033463: Edwards Lifesciences Research Medical Pediatric Arterial Cannulae, Edwards Lifesciences, LLC (2004) Summary page 1.

## Most influential descendants
- K140208: Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-Flexii (2014), 1 descendant of its own
- K200358: Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula (2020), 0 descendants of its own

## Recalls of this device
- Apr 9, 2014 · Class II · Z-1466-2014: Potential for separation of dilator tips.
- Apr 9, 2014 · Class II · Z-1467-2014: Potential for separation of dilator tips.
- Aug 26, 2013 · Class II · Z-0135-2014: Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.
- Mar 14, 2013 · Class II · Z-1111-2013: Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.

## Indications for use
Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral Access Cannula may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Source page: https://510kreport.com/device/K123298
Methodology: https://510kreport.com/methodology