# K033464: Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 22, 2004 after 235 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.
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. The FDA summary names its predicate without a number.
- (no number) Research Industries' Various Cardiovascular Devices: named in the summary without a submission number
- (no number) Research Medical, Inc. Fern-Flex Femoral Access Cannulation Kit: named in the summary without a submission number
- (no number) Terumo L-Series 1968 Type Pediatric Venous Catheters: named in the summary without a submission number

## Most influential descendants
- K123303: Femoral Access Venous Cannulae (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
- K120072: Venous Drainage Cannula with Duraflo Coating (2012), 0 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

## Indications for use
The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena cave during extracorporeal circulation for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cave during extracorporeal circulation for a duration < 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration < 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration < 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

Source page: https://510kreport.com/device/K033464
Methodology: https://510kreport.com/methodology