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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 K042489
Device Name 6F Z4 GUIDE CATHETER
Applicant
MEDTRONIC VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact FRED L BOUCHER
Correspondent
MEDTRONIC VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact FRED L BOUCHER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/14/2004
Decision Date 12/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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