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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-04-07 under 510(k) 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. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K152700.

When did StrataMR Valves and Shunts receive FDA 510(k) clearance?

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

Who is the listed applicant for StrataMR Valves and Shunts?

The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medtronic Neurosurgery as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JXG)

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Official Source

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

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