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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 K032622
Device Name ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE N.
FRIDLEY,  MN  55432 -3576
Applicant Contact LYNN JENSEN
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE N.
FRIDLEY,  MN  55432 -3576
Correspondent Contact LYNN JENSEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/26/2003
Decision Date 09/03/2003
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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