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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 K030671
Device Name MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB
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 Received03/03/2003
Decision Date 07/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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