Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface— 510(k) K223168

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K223168 for Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface, Substantially Equivalent on 2023-04-19. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code QWF
Advisory panel: Cardiovascular
Date received: 2022-10-11
Decision date: 2023-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

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