# K033463: Edwards Lifesciences Research Medical Pediatric Arterial Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jul 28, 2004 after 271 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite 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)
- 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 1964 Type Pediatric Aortic Cannulae: named in the summary without a submission number

## Most influential descendants
- 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
- K123370: EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion Aortic Perfusion Cannula (2013), 1 descendant of its own
- K233895: EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); (2024), 0 descendants 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
- Jan 21, 2011 · Not classified · Z-2196-2011: Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.

## Indications for use
(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA01SS, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place. (Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate. (Models FEMIJ010A, FEMII1O2A, FEMII014A, FEMII008AT, FEMIJ010AT, FEMIJ012AT, FEMIL014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.

Source page: https://510kreport.com/device/K033463
Methodology: https://510kreport.com/methodology