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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, flow directed
510(k) Number K012225
Device Name ATTAIN 6215 VENOGRAM BALLOON CATHETER
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact KAREN REIDT
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact KAREN REIDT
Regulation Number870.1240
Classification Product Code
DYG  
Date Received07/16/2001
Decision Date 08/28/2001
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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