StrataMR Valves and Shunts

• • Terminated Z-1702-2017 FDA Class I ·initiated 22 Feb 2017

  Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in CSF fluid performance. This condition may result in the following adverse health consequences: ventriculomegaly, headaches, nausea, vomiting and lethargy. If left untreated, underdrainage has the potential to lead to coma and death.

510(k) Number

K152700 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• StrataMR II Valves and Shunts

  Class II

  FDA 510(k) K212641 Active Cleared 16 Sep 2021

• Medtronic Ps Medical Strata Type Value Open recall

  Class II

  FDA 510(k) K060681 Active Cleared 15 Sep 2006

• Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701 and 41704-41715

  Class II

  FDA 510(k) K063836 Active Cleared 16 Aug 2007

• U-Clip Device

  Class II

  FDA 510(k) K062821 Active Cleared 19 Dec 2006

• Medtronic Strata Nsc Lumboperitoneal Valve and Shunt System Open recall

  Class II

  FDA 510(k) K123524 Active Cleared 13 Feb 2013

• Ps Medical Strata II Valve Open recall

  Class II

  FDA 510(k) K042465 Active Cleared 19 Oct 2004

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