# K212386: AngioVac F18 85

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Sep 30, 2021 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
Longest line of descent: 4 generations back to K091304 (2009). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190594: AngioVac C20, AngioVac C180, AngioDynamics, Inc. (2019) Summary page 4.

## Indications for use
The AngioVac F18 85 is indicated as a venous drainage cannula for the non-surgical removal of thrombi or emboli during extracorporeal bypass for up to 6 hours.

Source page: https://510kreport.com/device/K212386
Methodology: https://510kreport.com/methodology