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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 K223508
Device Name Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55448
Applicant Contact Rajitha Nair
Correspondent
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55448
Correspondent Contact Rajitha Nair
Regulation Number878.4400
Classification Product Code
OCL  
Date Received11/22/2022
Decision Date 12/22/2022
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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