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FDA 510(k)

StrataMR Valves and Shunts

K-Number: K152700 · 2016-04-07

ApplicantMedtronic Neurosurgery
Decision Date2016-04-07
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StrataMR Valves and Shunts is a medical device manufactured by Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-04-07 under approval number K152700. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StrataMR Valves and Shunts?

StrataMR Valves and Shunts is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Medtronic Neurosurgery. The 510(k) number is K152700.

When was StrataMR Valves and Shunts approved by the FDA?

StrataMR Valves and Shunts received FDA 510(k) clearance on 2016-04-07, under approval number K152700.

What company makes StrataMR Valves and Shunts?

StrataMR Valves and Shunts is manufactured by Medtronic Neurosurgery.

What is the FDA product code for StrataMR Valves and Shunts?

The FDA product code for StrataMR Valves and Shunts is JXG.

Other Devices by Medtronic Neurosurgery

K161370Durepair Dura Regeneration Matrix K181622StrataMR guider tool K212641StrataMR II Valves and Shunts K242034Duet External Drainage and Monitoring System (EDMS) K243676Duet External Drainage and Monitoring System (EDMS)

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation K172759Smart External Drain (SED) SystemAqueduct Critical Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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