Cardioblate Gemini-s Surgical Ablation Device

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Cardioblate Gemini-s Surgical Ablation Device.

Pre-market Notification Details

Device IDK200514
510k NumberK200514
Device Name:Cardioblate Gemini-s Surgical Ablation Device
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant Medtronic 7611 Northland Drive Minneapolis,  MN  55428
ContactRahul Shah
CorrespondentRahul Shah
Medtronic 7611 Northland Drive Minneapolis,  MN  55428
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169998032 K200514 000

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