# K172984: Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Nov 20, 2017 after 54 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- 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 K936003 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100645: Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface, Medtronic, Inc. (2012) Summary page 8.
- K141233: Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance Biosuface, Medtronic, Inc. (2014) Summary page 8.

## Indications for use
The Affinity Pixie hollow fiber oxygenator with Balance biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin. The Affinity Pixie hollow fiber oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine CPB procedures up to 6 hours in duration. The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Balance biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin. The Affinity Pixie hollow fiber oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine CPB procedures up to 6 hours in duration. The Affinity Pixie cardiotomy/ venous reservoir 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 (VA VD) procedures. The Affinity Pixie hollow fiber oxygenator with Cortiva bioactive surface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin. The Affinity Pixie hollow fiber oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine CPB procedures up to 6 hours in duration. The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 Lmin. The Affinity Pixie hollow fiber oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine CPB procedures up to 6 hours in duration. The Affinity Pixie cardiotomy/ venous reservoir 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.

Source page: https://510kreport.com/device/K172984
Methodology: https://510kreport.com/methodology