Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811)

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

510(k) Number

K240666 ↗

FDA Product Code

DTZ

Models / Variants

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811)

Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841)

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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