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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K121301
Device Name XPRESSWAY RX CATHETER (6F LD-VERISON)
Applicant
Kaneka Pharma America, LLC
546 Fifth Ave., 21st Floor
New York,  NY  10036
Applicant Contact JOSEPH DEPAOLO
Correspondent
Kaneka Pharma America, LLC
546 Fifth Ave., 21st Floor
New York,  NY  10036
Correspondent Contact JOSEPH DEPAOLO
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received05/01/2012
Decision Date 07/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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