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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 K191526
Device Name Cardioblate CryoFlex Surgical Ablation System
Applicant
Medtronic, Inc.
3800 Annapolis Ln.
Minneapolis,  MN  55447
Applicant Contact Choua Thao
Correspondent
Medtronic, Inc.
3800 Annapolis Ln.
Minneapolis,  MN  55447
Correspondent Contact Choua Thao
Regulation Number878.4400
Classification Product Code
OCL  
Date Received06/10/2019
Decision Date 10/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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