CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE

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

MEDTRONIC INC.

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

Pre-market Notification Details

Device IDK121767
510k NumberK121767
Device Name:CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactMary E Donlin
CorrespondentMary E Donlin
MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-15
Decision Date2012-07-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000841591 K121767 000

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