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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 K141175
Device Name RENOVOCATH RC120
Applicant
RENOVORX, INC.
755 N. MATHILDA AVE, STE 100
SUNNYVALE,  CA  94085
Applicant Contact RON S WARREN
Correspondent
RENOVORX, INC.
755 N. MATHILDA AVE, STE 100
SUNNYVALE,  CA  94085
Correspondent Contact RON S WARREN
Regulation Number870.4450
Classification Product Code
MJN  
Date Received05/06/2014
Decision Date 10/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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