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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 K982883
Device Name MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
Applicant
MEDTRONICS INTERVENTIONAL VASCULAR
35-37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact MARK CHARTIER
Correspondent
MEDTRONICS INTERVENTIONAL VASCULAR
35-37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact MARK CHARTIER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/17/1998
Decision Date 09/04/1998
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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