# K001138: Affinity 20 Micron Arterial Blood Filter with Carmeda Bioactive Surface, Models CB353/CB354

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Apr 27, 2000 after 17 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- 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
- K123351: Affinity AF100 Arterial Filter with Carmeda Bioactive Surface (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K001138
Methodology: https://510kreport.com/methodology