Cleared Traditional

RenovoCath

K160067 · Renovorx, Inc. · Cardiovascular

Mar 2017

Decision

419d

Days

Class 2

Risk

About This 510(k) Submission

K160067 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 March 7, 2017, 419 days after receiving the submission on January 13, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K160067 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2016
Decision Date	March 07, 2017
Days to Decision	419 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF