# K012325: Cardiovention Corx System, Model FG 0001

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovention, Inc.
- Decided: Apr 9, 2002 after 260 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
2 of 16 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) Optimin Hollow Fiber Oxygenator: named in the summary without a submission number
- (no number) Sarns Delphin Centrifugal Blood Pump: named in the summary without a submission number
- (no number) HVR2200 Hard Shell Venous Reservoir (defoamer): named in the summary without a submission number

## Most influential descendants
- K031700: Medtronic Resting Heart System, Model AAR1000 and 711 (2003), 13 descendants of its own
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K090006: Lifebridge B2T, Model 7001 (2009), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own

## Indications for use
The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal gas exchange support. This device can be used with a legally marketed thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting up to six hours. The CORXx System is intended for use with the Medtronic Bio-medicus Bio-Console.

Source page: https://510kreport.com/device/K012325
Methodology: https://510kreport.com/methodology