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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 K021587
Device Name ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
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 Number870.1250
Classification Product Code
DQY  
Date Received05/15/2002
Decision Date 05/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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