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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 K120808
Device Name EXPORT XT CATHETER, EXPORT AP CATHETER
Applicant
MEDTRONIC INC.
35-37a cherry hill drive
danvers,  MA  01923 5186
Contact anu gaur
Regulation Number870.5150
Classification Product Code
DXE  
Date Received03/16/2012
Decision Date 06/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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