Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen 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 Pen Surgical Ablation Device, Cardioblate Xl Pen Surgical Ablation Device.

Pre-market Notification Details

Device IDK190623
510k NumberK190623
Device Name:Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen 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 Received2019-03-11
Decision Date2019-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169997974 K190623 000
00643169997967 K190623 000

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