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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K120808
Device Name EXPORT XT CATHETER, EXPORT AP CATHETER
Applicant
Medtronic, Inc.
35-37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact ANU GAUR
Correspondent
Medtronic, Inc.
35-37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact ANU GAUR
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
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
Predetermined Change
Control Plan Authorized		 No
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