Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP 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 Valleylab Ft10 Electrosurgical Platform, Cardioblate Bp2 Surgical Ablation Device, Cardioblate Lp Surgical Ablation Device.

Pre-market Notification Details

Device IDK182610
510k NumberK182610
Device Name:Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant Medtronic 7611 Northland Drive Minneapolis,  MN  55428
ContactKari Christianson
CorrespondentKari Christianson
Medtronic 7611 Northland Drive Minneapolis,  MN  55428
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-21
Decision Date2018-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169998018 K182610 000
00643169997998 K182610 000

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