# K142607: AngioVac Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Angiodynamics
- Decided: Dec 11, 2014 after 87 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- 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: 4 generations back to K895753 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit, Vortex Medical, Inc. (2009) Summary page 4.

## Recalls of this device
- Mar 21, 2016 · Class II · Z-1702-2016: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the 

## Indications for use
The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

Source page: https://510kreport.com/device/K142607
Methodology: https://510kreport.com/methodology