# K012774: Jostra Arterial Perfusion Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Jostra AG
- Decided: Nov 16, 2001 after 88 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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) Medtronic DLP Adult Arterial Cannulae: named in the summary without a submission number

## Recalls of this device
- May 14, 2018 · Class II · Z-2160-2018: This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
- May 14, 2018 · Class II · Z-2159-2018: This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
- May 14, 2018 · Class II · Z-2161-2018: This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

## Indications for use
The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.

Source page: https://510kreport.com/device/K012774
Methodology: https://510kreport.com/methodology