K240666

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)

510(k) number: K240666
Device name: 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)
Applicant: Medtronic Perfusion Systems MN · US
Product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Decision date: 2024-07-10
Date received: 2024-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain

Also available from FDA: K240666.pdf

Official FDA record: K240666

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.