# K023251: Pediatric Arterial Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Polystan A/S
- Decided: Dec 4, 2002 after 65 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
Longest line of descent: 1 generation back to K012617 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012617: Jostra Arterial Perfusion Cannulae, Model a..., Jostra AG (2001)

## Recalls of this device
- May 29, 2012 · Class II · Z-2210-2012: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

## Indications for use
The Pediatric Arterial Cannula is used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.

Source page: https://510kreport.com/device/K023251
Methodology: https://510kreport.com/methodology