Cleared Special

RenovoCath

K212324 · Renovorx, Inc. · Cardiovascular

Aug 2021

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K212324 is an FDA 510(k) clearance for the RenovoCath, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Renovorx, Inc. (Los Altos, US). The FDA issued a Cleared decision on August 23, 2021, 28 days after receiving the submission on July 26, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K212324 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2021
Decision Date	August 23, 2021
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF