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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, embolectomy
510(k) Number K121301
Device Name XPRESSWAY RX CATHETER (6F LD-VERISON)
Original Applicant
KANEKA PHARMA AMERICA LLC
546 fifth ave., 21st floor
new york,  NY  10036
Original Contact joseph depaolo
Regulation Number870.5150
Classification Product Code
DXE  
Date Received05/01/2012
Decision Date 07/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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