# K033468: Affinity 20U Arterial Filter with Trillium Biosurface

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Nov 14, 2003 after 11 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
Longest line of descent: 2 generations back to K926413 (1993). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994208: Affinity 20 Micron Arterial Blood Filter, Model 353/354, Medtronic Perfusion Systems (2000) Summary page 1.
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface, Avecor Cardiovascular, Inc. (1998) Summary page 1.

## Most influential descendants
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own

## Indications for use
The AFFINITY@Arterial Filter with TrilliumTMBiosurface is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

Source page: https://510kreport.com/device/K033468
Methodology: https://510kreport.com/methodology