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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 K082670
Device Name MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
Applicant
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact BETH CLAAS
Correspondent
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact BETH CLAAS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/15/2008
Decision Date 12/04/2008
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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