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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 K081573
Device Name MEDTRONIC EXPORT AP CATHETER
Applicant
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact TARA N TURNEY
Correspondent
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact TARA N TURNEY
Regulation Number870.5150
Classification Product Code
DXE  
Date Received06/05/2008
Decision Date 06/27/2008
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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