Cleared Traditional

RenovoCath

K191606 · Renovorx, Inc. · Cardiovascular

Aug 2019

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K191606 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 7, 2019, 51 days after receiving the submission on June 17, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K191606 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2019
Decision Date	August 07, 2019
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF