Cleared Traditional

RENOVOCATH RC120

K141175 · Renovorx, Inc. · Cardiovascular

Oct 2014

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K141175 is an FDA 510(k) clearance for the RENOVOCATH RC120, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Renovorx, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 24, 2014, 171 days after receiving the submission on May 6, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K141175 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2014
Decision Date	October 24, 2014
Days to Decision	171 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF