# 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);

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences
- Decided: Feb 5, 2024 after 56 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
Longest line of descent: 2 generations back to K831769 (1983). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123370: EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion Aortic Perfusion Cannula, Edwards Lifesciences, LLC (2013) Summary page 6.
- K073559: 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula II, Edwards Lifesciences Research Medical (2008) Summary page 6.
- K971291: Heartport Endoarterial Return Cannula, Heartport, Inc. (1997) Summary page 6.

## Indications for use
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for < 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch. The EndoReturn arterial cannula are indicated for patients undergoing cardiopulmonary bypass. They are intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The EndoReturn arterial cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the EndoClamp aortic catheter. Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤6 hours) cardiopulmonary bypass procedures. Aortic perfusion cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.

Source page: https://510kreport.com/device/K233895
Methodology: https://510kreport.com/methodology