MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

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 Medtronic Strata Nsc Lumboperitoneal Valve And Shunt System.

Pre-market Notification Details

Device IDK123524
510k NumberK123524
Device Name:MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
ClassificationShunt, Central Nervous System And Components
Applicant MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
ContactDonovan May
CorrespondentDonovan May
MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-15
Decision Date2013-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994653352 K123524 000
00763000027179 K123524 000
00763000027513 K123524 000
00763000027520 K123524 000
00763000027537 K123524 000
00763000027773 K123524 000
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00643169010772 K123524 000
00643169010789 K123524 000
00643169010796 K123524 000
00613994653345 K123524 000
00763000027162 K123524 000

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