FDA 510(k)

MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM

K-Number: K123524 · 2013-02-13

Decision Date2013-02-13

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2013-02-13 under 510(k) number K123524. 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 MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM?

MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-13. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K123524.

When did MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM receive FDA 510(k) clearance?

MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM received FDA 510(k) clearance on 2013-02-13, under 510(k) number K123524.

Who is the listed applicant for MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM?

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 MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM?

The FDA product code for MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM is 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.