# K994208: Affinity 20 Micron Arterial Blood Filter, Model 353/354

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Jan 13, 2000 after 30 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: 1 generation back to K926413 (1993). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952532: Affinity Arterial Blood Filter, Avecor Cardiovascular, Inc. (1995) Summary page 1.
- K926413: Medtronic Arterial Filter, Medtronic Vascular (1993) Summary page 1.

## Most influential descendants
- K033468: Affinity 20U Arterial Filter with Trillium Biosurface (2003), 7 descendants of its own
- 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

## Indications for use
The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

Source page: https://510kreport.com/device/K994208
Methodology: https://510kreport.com/methodology