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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular occluding, temporary
510(K) Number K122576
Device Name TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
Applicant
STRYKER NEUROVASCULAR
47900 bayside parkway
fremont,  CA  94538
Contact james leathley
Regulation Number870.4450
Classification Product Code
MJN  
Date Received08/23/2012
Decision Date 01/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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