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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 a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2023-04-19 under approval 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. It is manufactured by Medtronic, Inc.. The 510(k) number is K223168.

When was Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface approved by the FDA?

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

What company makes 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 manufactured by Medtronic, Inc..

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

NCT04047784 Pilot Study to Evaluate the Role of EBUS in the Diagnosis of Acute PE in Critically Ill Patients ENROLLING_BY_INVITATION NCT07566702 Effect of Neuromuscular Electrical Stimulation on Muscle Mass in ECMO Patients NOT_YET_RECRUITING NCT06336655 Physiology of Unloading VA ECMO Trial RECRUITING NCT07387276 "Recovery Techniques on Pain, Force and Muscle Oxygenation in Athletes: A Crossover Trial" NOT_YET_RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT06814340 "Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme" RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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