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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K142684
Device Name FlexCath Select Steerable Sheath (10 French)
Applicant
Medtronic Cryocath, LP
8200 Coral Sea St. NE
Mailstop Mvs46
Mounds View,  MN  55112
Applicant Contact Vanessa Ware
Correspondent
Medtronic Cryocath, LP
8200 Coral Sea St. NE
Mailstop Mvs46
Mounds View,  MN  55112
Correspondent Contact Vanessa Ware
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/19/2014
Decision Date 11/06/2014
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
Recalls CDRH Recalls
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