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

Name: FDA 510(k) clearance K223168
Creator: U.S. Food and Drug Administration
Published: 2023-04-19

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.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code QWF
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2022-10-11
Decision date: 2023-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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