# K905312: Duraflo II Heparin Treated Femoral Cannulae Models

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Bentley Laboratories, Inc.
- Decided: Jan 15, 1991 after 48 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has 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
- K123303: Femoral Access Venous Cannulae (2013), 2 descendants of its own
- K123298: Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating (2013), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K905312
Methodology: https://510kreport.com/methodology