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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K131332
Device Name CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
Applicant
Cardiosolutions, Inc.
375 W. St.
West Bridgewater,  MA  02379
Applicant Contact MICHELE LUCE
Correspondent
Cardiosolutions, Inc.
375 W. St.
West Bridgewater,  MA  02379
Correspondent Contact MICHELE LUCE
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DRA  
Date Received05/09/2013
Decision Date 07/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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