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FDA 510(k)

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface

K-Number: K223168 · 2023-04-19

ApplicantMedtronic, Inc.
Decision Date2023-04-19
Product CodeQWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K223168. The device is classified under product code QWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface?

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Medtronic, Inc.. The 510(k) number is K223168.

When did Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface receive FDA 510(k) clearance?

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface received FDA 510(k) clearance on 2023-04-19, under 510(k) number K223168.

Who is the listed applicant for Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface?

The FDA product code for Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface is QWF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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