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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 K132673
Device Name 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
Applicant
MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Applicant Contact HEATHER MOROSE
Correspondent
MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS,  MA  01923
Correspondent Contact HEATHER MOROSE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/27/2013
Decision Date 10/22/2013
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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