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510(k) K223508

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device by Medtronic, Inc. — Product Code OCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2022
Date Received
November 22, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

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