Cleared Traditional

K240666 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) (FDA 510(k) Clearance)

Also includes:

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)

K240666 · Medtronic Perfusion Systems · Cardiovascular device

Jul 2024

Decision

124d

Days

Class 2

Risk

K240666 is an FDA 510(k) clearance for the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811). This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on July 10, 2024, 124 days after receiving the submission on March 8, 2024.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number	K240666 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 2024
Decision Date	July 10, 2024
Days to Decision	124 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF