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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K240880.

When did VitalFlow Set with Balance Biosurface receive FDA 510(k) clearance?

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

Who is the listed applicant for VitalFlow Set 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 VitalFlow Set with Balance Biosurface?

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

Related Clinical Trials

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Related Devices (Code: QJZ)

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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.