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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 K190623
Device Name Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
Applicant
Medtronic
7611 Northland Drive
Minneapolis,  MN  55428
Applicant Contact Rahul Shah
Correspondent
Medtronic
7611 Northland Drive
Minneapolis,  MN  55428
Correspondent Contact Rahul Shah
Regulation Number878.4400
Classification Product Code
OCL  
Date Received03/11/2019
Decision Date 05/30/2019
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
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