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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K160067
Device Name RenovoCath
Applicant
Renovorx, Inc.
4546 El Camino Real, Suite 282
Los Altos,  CA  94022
Applicant Contact Kamran Najmabadi
Correspondent
Experien Group, LLC
755 N. Mathilda Ave.
Sunnyvale,  CA  94085
Correspondent Contact Ronald S. Warren
Regulation Number870.4450
Classification Product Code
MJN  
Date Received01/13/2016
Decision Date 03/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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