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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 K061416
Device Name SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
Applicant
MEDTRONIC VASCULAR
1015 GRAMSIE ROAD
SHOREVIEW,  MN  55126 -3082
Applicant Contact MICHELLE NIVALA
Correspondent
MEDTRONIC VASCULAR
1015 GRAMSIE ROAD
SHOREVIEW,  MN  55126 -3082
Correspondent Contact MICHELLE NIVALA
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/22/2006
Decision Date 10/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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