Visualase MRI-Guided Laser Ablation System (SW 3.4)

Neurosurgical Laser With Mr Thermography

Medtronic Navigation, Inc.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Visualase Mri-guided Laser Ablation System (sw 3.4).

Pre-market Notification Details

Device IDK211269
510k NumberK211269
Device Name:Visualase MRI-Guided Laser Ablation System (SW 3.4)
ClassificationNeurosurgical Laser With Mr Thermography
Applicant Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville,  CO  80027
ContactSharon Mcdermott
CorrespondentSharon Mcdermott
Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville,  CO  80027
Product CodeONO  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-27
Decision Date2022-01-07

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