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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 K031211
Device Name ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
Applicant
Medtronic Vascular
7000 Central Ave. NE
Ms Cw 304
Minneapolis,  MN  55432 -3576
Applicant Contact LYNN JENSEN
Correspondent
Medtronic Vascular
7000 Central Ave. NE
Ms Cw 304
Minneapolis,  MN  55432 -3576
Correspondent Contact LYNN JENSEN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/17/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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