FDA 510(k)

STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836

K-Number: K083076 · 2008-11-20

Decision Date2008-11-20

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2008-11-20 under 510(k) number K083076. 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 STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836?

STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 is a medical device that received FDA 510(k) clearance on 2008-11-20. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K083076.

When did STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 receive FDA 510(k) clearance?

STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 received FDA 510(k) clearance on 2008-11-20, under 510(k) number K083076.

Who is the listed applicant for STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836?

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 STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836?

The FDA product code for STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 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.