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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 the device name listed in this FDA 510(k) record. The listed applicant is Renovorx, Inc.. It received FDA 510(k) clearance on 2021-08-23 under 510(k) 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. The listed applicant is Renovorx, Inc.. The 510(k) number is K212324.

When did RenovoCath receive FDA 510(k) clearance?

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

Who is the listed applicant for RenovoCath?

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

What is the FDA product code for RenovoCath?

The FDA product code for RenovoCath is MJN.

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.

NCT03257033Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPCRECRUITING

Other records listing Renovorx, Inc. as applicant

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.

K191606RenovoCathK160067RenovoCath

Related Devices (Code: MJN)

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.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK210602AortaSTAT Occlusion DeviceRenalpro Medical, Inc.

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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