StrataMR Guider Tool

Shunt, Central Nervous System And Components

Medtronic Neurosurgery

The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Stratamr Guider Tool.

Pre-market Notification Details

Device IDK181622
510k NumberK181622
Device Name:StrataMR Guider Tool
ClassificationShunt, Central Nervous System And Components
Applicant Medtronic Neurosurgery 125 Cremona Dr Goleta,  CA  93117
ContactXiaojian Sun
CorrespondentXiaojian Sun
Medtronic Neurosurgery 125 Cremona Dr Goleta,  CA  93117
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-20
Decision Date2018-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000067588 K181622 000

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