Affinity 20 Micron Arterial Blood Filter, Model 353/354

No FDA recalls found in the data synced 24 Oct 2026.

510(k) Number

K994208 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Medtronic Perfusion Systems →

• What is the Affinity 20 Micron Arterial Blood Filter used for?

  The Affinity 20 Micron Arterial Blood Filter is designed for cardiopulmonary bypass surgery to filter blood in extracorporeal circuits, removing particulate and gaseous microemboli through its 20-micron pore size screen before returning the blood to the patient.

• Is the Affinity 20 Micron Arterial Blood Filter single-use or reusable?

  The Affinity 20 Micron Arterial Blood Filter is supplied as a single-use product, meaning it should be discarded after one use to ensure patient safety and maintain the device's filtering effectiveness.

• What are the specifications of the Affinity 20 Micron Arterial Blood Filter?

  The Affinity 20 Micron Arterial Blood Filter features a 20-micron pore size screen designed to remove particulate and gaseous microemboli during cardiopulmonary bypass surgery. It is available in models 353/354 and is manufactured by Medtronic Perfusion Systems.

• What is the regulatory status of the Affinity 20 Micron Arterial Blood Filter?

  The Affinity 20 Micron Arterial Blood Filter has received FDA 510(k) clearance with the K number K994208, indicating it has been determined to be substantially equivalent to existing devices for its intended use in cardiopulmonary bypass procedures.