StrataMR II Valves And Shunts

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 Ii Valves And Shunts.

Pre-market Notification Details

Device IDK212641
510k NumberK212641
Device Name:StrataMR II Valves And Shunts
ClassificationShunt, Central Nervous System And Components
Applicant Medtronic Neurosurgery 5290 California Avenue Irvine,  CA  92617
ContactSwara Vashi
CorrespondentSudeep Nambiar
Medtronic Neurosurgery 5290 California Avenue Irvine,  CA  92617
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-20
Decision Date2021-09-16

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