Cleared Traditional

K152700 - StrataMR Valves and Shunts (FDA 510(k) Clearance)

K152700 · Medtronic Neurosurgery · Neurology device
Apr 2016
Decision
199d
Days
Class 2
Risk

K152700 is an FDA 510(k) clearance for the StrataMR Valves and Shunts. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on April 7, 2016, 199 days after receiving the submission on September 21, 2015.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K152700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date April 07, 2016
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.5550