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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 K061119
Device Name ENPATH MEDICAL STEERABLE SHEATH
Applicant
ENPATH MEDICAL, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Applicant Contact JAMES JENKINS
Correspondent
ENPATH MEDICAL, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Correspondent Contact JAMES JENKINS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/21/2006
Decision Date 05/18/2006
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
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