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FDA 510(k)

RenovoCath

K-Number: K160067 · 2017-03-07

ApplicantRenovorx, Inc.
Decision Date2017-03-07
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RenovoCath is a medical device manufactured by Renovorx, Inc.. It received FDA 510(k) clearance on 2017-03-07 under approval number K160067. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RenovoCath?

RenovoCath is a medical device that received FDA 510(k) clearance on 2017-03-07. It is manufactured by Renovorx, Inc.. The 510(k) number is K160067.

When was RenovoCath approved by the FDA?

RenovoCath received FDA 510(k) clearance on 2017-03-07, under approval number K160067.

What company makes RenovoCath?

RenovoCath is manufactured by Renovorx, Inc..

What is the FDA product code for RenovoCath?

The FDA product code for RenovoCath is MJN.

Other Devices by Renovorx, Inc.

K191606RenovoCath K212324RenovoCath

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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.

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