# K992910: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance Biocompatible Surface (Model 511B)

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Sep 15, 1999 after 16 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K984271: Modification of Maxima Forte' Hollow Fiber Oxygenator with Balance Biocompatible Surface with Plasma Resistent Fiber (M0, Medtronic Vascular (1999) Summary page 1.

## Indications for use
The Medtronic AFFINITY® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface is intended for use 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/K992910
Methodology: https://510kreport.com/methodology