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FDA 510(k)

RenovoCath

K-Number: K212324 · 2021-08-23

ApplicantRenovorx, Inc.
Decision Date2021-08-23
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RenovoCath is a medical device manufactured by Renovorx, Inc.. It received FDA 510(k) clearance on 2021-08-23 under approval number K212324. 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 2021-08-23. It is manufactured by Renovorx, Inc.. The 510(k) number is K212324.

When was RenovoCath approved by the FDA?

RenovoCath received FDA 510(k) clearance on 2021-08-23, under approval number K212324.

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.

K160067RenovoCath K191606RenovoCath

Related Devices (Code: MJN)

K160598REBOA Balloon CatheterNuMED, Inc. K153530Bridge Occlusion BalloonSpectranetics, Inc. K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. K172790ER-REBOA CatheterPrytime Medical Devices, Inc. K170411ER-REBOA CatheterPrytime Medical Devices, Inc. K160067RenovoCathRenovorx, Inc.

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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