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FDA 510(k)

VitalFlow Set with Balance Biosurface

K-Number: K240880 · 2024-09-12

Decision Date2024-09-12
Product CodeQJZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitalFlow Set with Balance Biosurface is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2024-09-12 under approval number K240880. The device is classified under product code QJZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalFlow Set with Balance Biosurface?

VitalFlow Set with Balance Biosurface is a medical device that received FDA 510(k) clearance on 2024-09-12. It is manufactured by Medtronic, Inc.. The 510(k) number is K240880.

When was VitalFlow Set with Balance Biosurface approved by the FDA?

VitalFlow Set with Balance Biosurface received FDA 510(k) clearance on 2024-09-12, under approval number K240880.

What company makes VitalFlow Set with Balance Biosurface?

VitalFlow Set with Balance Biosurface is manufactured by Medtronic, Inc..

What is the FDA product code for VitalFlow Set with Balance Biosurface?

The FDA product code for VitalFlow Set with Balance Biosurface is QJZ.

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Official Source

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