StrataMR II Valves and Shunts
K-Number: K212641 · 2021-09-16
ApplicantMedtronic Neurosurgery
Decision Date2021-09-16
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
StrataMR II Valves and Shunts is a medical device manufactured by Medtronic Neurosurgery. It received FDA 510(k) clearance on 2021-09-16 under approval 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. It is manufactured by Medtronic Neurosurgery. The 510(k) number is K212641.
When was StrataMR II Valves and Shunts approved by the FDA?
StrataMR II Valves and Shunts received FDA 510(k) clearance on 2021-09-16, under approval number K212641.
What company makes StrataMR II Valves and Shunts?
StrataMR II Valves and Shunts is manufactured by Medtronic Neurosurgery.
What is the FDA product code for StrataMR II Valves and Shunts?
The FDA product code for StrataMR II Valves and Shunts is JXG.
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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.