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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K123591
Device Name FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
Applicant
Medtronic Cryocath, LP
8200 Coral Sea St. N.E, Ms Mvs46
Mounds View,  MN  55112
Applicant Contact VANESSA WARE
Correspondent
Medtronic Cryocath, LP
8200 Coral Sea St. N.E, Ms Mvs46
Mounds View,  MN  55112
Correspondent Contact VANESSA WARE
Regulation Number870.1280
Classification Product Code
DRA  
Date Received11/21/2012
Decision Date 12/27/2012
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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