# K911789: Minimax (TM) Hardshell Venous Res W/Inte Card Filt

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 20, 1991 after 120 days
- Product code: DTP (Defoamer, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K100645: Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface (2012), 4 descendants of its own
- K141233: Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance Biosuface (2014), 1 descendant of its own
- K172984: Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface (2017), 0 descendants of its own
- K160091: Temperature Probe, Affinity Temperature Probe (2016), 0 descendants of its own
- K123448: Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with Carmeda Bioactive (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K911789
Methodology: https://510kreport.com/methodology