StrataMR 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 Valves And Shunts.

Pre-market Notification Details

Device IDK152700
510k NumberK152700
Device Name:StrataMR Valves And Shunts
ClassificationShunt, Central Nervous System And Components
Applicant MEDTRONIC NEUROSURGERY 125 CREMONA DRIVE Goleta,  CA  93117
ContactMicah Schloss
CorrespondentDeep Pal
MEDTRONIC NEUROSURGERY 125 CREMONA DRIVE Goleta,  CA  93117
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-21
Decision Date2016-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169692886 K152700 000
00643169692718 K152700 000
00643169692701 K152700 000
00643169616486 K152700 000
00643169616479 K152700 000
00643169616462 K152700 000
00643169616455 K152700 000
00643169593442 K152700 000
00643169593435 K152700 000

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