# K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Vortex Medical, Inc.
- Decided: Aug 28, 2009 after 15 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: 3 generations back to K895753 (1989). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013578: Pump Tubing, Terumo Cardiovascular Systems Corp. (2002) Summary page 1.
- K833322: Tubing Connectors EC-2XXX Series, Gish Biomedical, Inc. (1983) Summary page 1.
- K030077: Gish Tubing and Connectors with GBS Coating, Gish Biomedical, Inc. (2003) Summary page 1.
- K041697: Terumo Circuit Connectors, Terumo Cardiovascular Systems Corporation (2004) Summary page 1.
- K881330: Cobe Heart/Lung Perfusion and Cardioplegia Pack, Cobe Laboratories, Inc. (1988) Summary page 1.
- K771692: Tubing Sets, Cobe Laboratories, Inc. (1977) Summary page 1.
- K053025: Jostra HLM Tubing Set, Maquet Cardiopulmonary, AG (2005) Summary page 1.

## Most influential descendants
- K142607: AngioVac Circuit (2014), 0 descendants of its own

## Recalls of this device
- Mar 21, 2016 · Class II · Z-1701-2016: 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
Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

Source page: https://510kreport.com/device/K092486
Methodology: https://510kreport.com/methodology