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FDA 510(k)

VS3-IR

K-Number: K191851 · 2019-11-25

ApplicantMedtronic
Decision Date2019-11-25
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VS3-IR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K191851. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VS3-IR?

VS3-IR is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Medtronic. The 510(k) number is K191851.

When did VS3-IR receive FDA 510(k) clearance?

VS3-IR received FDA 510(k) clearance on 2019-11-25, under 510(k) number K191851.

Who is the listed applicant for VS3-IR?

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

What is the FDA product code for VS3-IR?

The FDA product code for VS3-IR is OWN.

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.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITINGNCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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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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