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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 K032312
Device Name ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE N.
FRIDLEY,  MN  55432 -3576
Applicant Contact KRISTINA MOLLNER
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE N.
FRIDLEY,  MN  55432 -3576
Correspondent Contact KRISTINA MOLLNER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/28/2003
Decision Date 10/21/2003
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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