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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K123733
Device Name CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Ms Mvs83
Mounds View,  MN  55112
Applicant Contact KARI CHRISTIANSON
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Ms Mvs83
Mounds View,  MN  55112
Correspondent Contact KARI CHRISTIANSON
Regulation Number878.4400
Classification Product Code
OCL  
Date Received12/05/2012
Decision Date 04/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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