CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205

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 Maps Surgical Mapping, Ablation, Pacing And Sensing Device, Model 49205.

Pre-market Notification Details

Device IDK090721
510k NumberK090721
Device Name:CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant Medtronic 8200 CORAL SEA STREET NE Minneapolis,  MN  55428
ContactPeter Liu
CorrespondentPeter Liu
Medtronic 8200 CORAL SEA STREET NE Minneapolis,  MN  55428
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-18
Decision Date2009-06-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.