# K962641: Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Dec 16, 1996 after 164 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 K872107 (1987). 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)
- K941473: Maxima Plus Hollow Fiber Oxygenator, Medtronic Vascular (1995) Summary page 1.
- K872107: William Harvey HF5000 Membrane Oxygenator, Minntech Corp. (1987) Summary page 1.

## Indications for use
MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood and is designed to operate at blood flow rates between 1 and 7 liters per minute for periods up to six hours.

Source page: https://510kreport.com/device/K962641
Methodology: https://510kreport.com/methodology