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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 K112382
Device Name TERUMO ASPRIATION CATHETER
Original Applicant
TERUMO MEDICAL CORPORATION
950 elkton blvd
elkton,  MD  21921
Original Contact daniel r plonski
Regulation Number870.5150
Classification Product Code
DXE  
Date Received08/18/2011
Decision Date 12/14/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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