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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 K083422
Device Name 6F TAIGA GUIDING CATHETER
Applicant
MEDTRONIC VASCULAR
37A CHERRY HILL DRIVE
danvers,  MA  01923
Applicant Contact vic zhang
Correspondent
MEDTRONIC VASCULAR
37A CHERRY HILL DRIVE
danvers,  MA  01923
Correspondent Contact vic zhang
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/19/2008
Decision Date 02/06/2009
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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