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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 K062420
Device Name 5F SHERPA ACTIVE 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 Received08/18/2006
Decision Date 09/08/2006
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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