# K984271: Modification of Maxima Forte' Hollow Fiber Oxygenator with Balance Biocompatible Surface with Plasma Resistent Fiber (M0

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Mar 9, 1999 after 99 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992910: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance Biocompatible Surface (Model 511B) (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K984271
Methodology: https://510kreport.com/methodology