# K091304: Vortex Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Vortex Medical, Inc.
- Decided: Jul 2, 2009 after 59 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices 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) Estech Remote Access Perfusion Femoral Venous Cannula: named in the summary without a submission number

## Most influential descendants
- K133445: Angiovac Cannula (2014), 4 descendants of its own
- K142593: AngioVac Cannula (2014), 3 descendants of its own
- K190594: AngioVac C20, AngioVac C180 (2019), 2 descendants of its own
- K253106: AngioVac Cannula (2025), 0 descendants of its own
- K212386: AngioVac F18 85 (2021), 0 descendants of its own

## Indications for use
The Vortex Cannula is intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours.

Source page: https://510kreport.com/device/K091304
Methodology: https://510kreport.com/methodology