# K101186: Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding Bag

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Perfusion Systems
- Decided: Sep 3, 2010 after 128 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

Source page: https://510kreport.com/device/K101186
Methodology: https://510kreport.com/methodology