# K002857: Els Cannula (Kit), Model M1210-88,M1510-88

- Pathway: 510(k) (Traditional)
- Applicant: Jostra AG
- Decided: Oct 5, 2000 after 22 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.
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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 26, 2012 · Class II · Z-0839-2013: ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

Source page: https://510kreport.com/device/K002857
Methodology: https://510kreport.com/methodology