# K073559: 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula II

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences Research Medical
- Decided: Jan 31, 2008 after 43 days
- Product code: DQR (Cannula, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1300
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 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) Edwards Lifesciences Arterial Perfusion Cannula: named in the summary without a submission number

## Most influential descendants
- 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

## Recalls of this device
- May 14, 2025 · Class I · Z-2081-2025: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- May 14, 2025 · Class I · Z-2080-2025: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Mar 7, 2018 · Class II · Z-3034-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

## Indications for use
The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.

Source page: https://510kreport.com/device/K073559
Methodology: https://510kreport.com/methodology