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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 K013963
Device Name MODEL 9210 DELIVERY CATHETER, MODEL 9210
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact MARY E BEST
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact MARY E BEST
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/03/2001
Decision Date 02/28/2002
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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