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510(k) K152700

StrataMR Valves and Shunts by Medtronic Neurosurgery — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2016
Date Received
September 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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  • K243205 — EVAC (June 3, 2025)
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