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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Cutting/Scoring
510(k) Number K163380
Device Name Serranator Alto PTA Serration Balloon Catheter
Applicant
Cagent Vascular, LLC
150 Strafford Ave. #315
Wayne,  PA  19087
Applicant Contact Carol Burns
Correspondent
Cagent Vascular, LLC
150 Strafford Ave. #315
Wayne,  PA  19087
Correspondent Contact Carol Burns
Regulation Number870.1250
Classification Product Code
PNO  
Date Received12/01/2016
Decision Date 02/13/2017
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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