FDA 510(k)

StrataMR II Valves and Shunts

K-Number: K212641 · 2021-09-16

Decision Date2021-09-16

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

StrataMR II 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 2021-09-16 under 510(k) number K212641. 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 II Valves and Shunts?

StrataMR II Valves and Shunts is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K212641.

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

StrataMR II Valves and Shunts received FDA 510(k) clearance on 2021-09-16, under 510(k) number K212641.

Who is the listed applicant for StrataMR II 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 II Valves and Shunts?

The FDA product code for StrataMR II 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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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.