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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
Original Applicant
MEDTRONIC INC.
35-37a cherry hill drive
danvers,  MA  01923 -5186
Original Contact anu gaur
Regulation Number870.5150
Classification Product Code
DXE  
Date Received03/16/2012
Decision Date 06/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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