# K143073: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Mar 25, 2015 after 149 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: 1 generation back to K932252 (1993). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932252: Affinity Hollow Fiber Oxygenator, Avecor Cardiovascular, Inc. (1993) Summary page 4.
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface, Avecor Cardiovascular, Inc. (1998) Summary page 4.
- K000430: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive Surface, Model CB511, Medtronic Vascular (2000) Summary page 4.

## Most influential descendants
- K162896: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface (2016), 0 descendants of its own
- K162016: Affinity NT Oxygenator with Cortiva BioActive Surface (2016), 0 descendants of its own

## Indications for use
Model 511: The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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 cardiopulmonary bypass procedures up to 6 hours in duration. Model CB511: The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda BioActive Surface 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 cardiopulmonary bypass procedures up to 6 hours in duration. Model 511T: The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Trillium Biosurface 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 cardiopulmonary bypass procedures up to 6 hours in duration.

Source page: https://510kreport.com/device/K143073
Methodology: https://510kreport.com/methodology