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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K060418
Device Name 8F SHERPA NX GUIDE CATHETER
Applicant
MEDTRONIC VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact MARK PUOPOLO
Correspondent
MEDTRONIC VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact MARK PUOPOLO
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/17/2006
Decision Date 03/15/2006
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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