# K122914: Affinity Fusion Cardiotomy/Venous Reservior with Balance Biosurface Model BB841, Affinity Fusion Cardiotomy/ Venous Rese

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jan 9, 2013 after 110 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0936003: Affinity® NT Cardiotomy/Venous Reservoir with Filter Model 540. Number could not be read

## Most influential descendants
- K132972: Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface (2013), 1 descendant of its own
- K172626: Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir (2017), 0 descendants of its own

## Indications for use
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

Source page: https://510kreport.com/device/K122914
Methodology: https://510kreport.com/methodology