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FDA 510(k)

Reprocessed Visions PV .035 Digital IVUS Catheter

K-Number: K181126 · 2019-01-18

ApplicantInnovative Health, LLC
Decision Date2019-01-18
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Visions PV .035 Digital IVUS Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2019-01-18 under approval number K181126. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Visions PV .035 Digital IVUS Catheter?

Reprocessed Visions PV .035 Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Innovative Health, LLC. The 510(k) number is K181126.

When was Reprocessed Visions PV .035 Digital IVUS Catheter approved by the FDA?

Reprocessed Visions PV .035 Digital IVUS Catheter received FDA 510(k) clearance on 2019-01-18, under approval number K181126.

What company makes Reprocessed Visions PV .035 Digital IVUS Catheter?

Reprocessed Visions PV .035 Digital IVUS Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Visions PV .035 Digital IVUS Catheter?

The FDA product code for Reprocessed Visions PV .035 Digital IVUS Catheter is OWQ.

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Related Devices (Code: OWQ)

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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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