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FDA 510(k)

VitalFlow Set with Balance™ Biosurface

K-Number: K261335 · 2026-07-31

ApplicantMedtronic, Inc.
Decision Date2026-07-31
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 2026-07-31 under 510(k) number K261335. 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 2026-07-31. The listed applicant is Medtronic, Inc.. The 510(k) number is K261335.

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

VitalFlow Set with Balance™ Biosurface received FDA 510(k) clearance on 2026-07-31, under 510(k) number K261335.

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

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.

NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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Related Devices (Code: QJZ)

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

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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