# K925626: Maxima Plus Hollow Fiber Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Feb 5, 1993 after 91 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K060155: 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (2006), 3 descendants of its own
- K073093: Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, (2008), 0 descendants of its own
- K063441: 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (2007), 0 descendants of its own
- K063431: 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K925626
Methodology: https://510kreport.com/methodology