Strata Nsc Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635

• • Terminated Z-1121-2017 FDA Class II ·initiated 17 Jan 2017

  Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.

510(k) Number

K082127 ↗

FDA Product Code

JXG

Models / Variants

Strata Nsc Burr Hole Valve, Model 42335

Shunt Assembly, Model 46635

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medtronic Neurosurgery →