CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING 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 Maps Surgical Mapping, Ablation, Pacing , And Sensing Device.

Pre-market Notification Details

Device IDK121451
510k NumberK121451
Device Name:CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING 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 Donlin
CorrespondentMary 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 Received2012-05-16
Decision Date2012-06-14
Summary:summary

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