FDA 510(k)

SHUNT TAP WITH ICP MONITORING ACCESS PORT

K-Number: K964371 · 1997-01-31

Decision Date1997-01-31

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SHUNT TAP WITH ICP MONITORING ACCESS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurocare, LLC. It received FDA 510(k) clearance on 1997-01-31 under 510(k) number K964371. 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 SHUNT TAP WITH ICP MONITORING ACCESS PORT?

SHUNT TAP WITH ICP MONITORING ACCESS PORT is a medical device that received FDA 510(k) clearance on 1997-01-31. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K964371.

When did SHUNT TAP WITH ICP MONITORING ACCESS PORT receive FDA 510(k) clearance?

SHUNT TAP WITH ICP MONITORING ACCESS PORT received FDA 510(k) clearance on 1997-01-31, under 510(k) number K964371.

Who is the listed applicant for SHUNT TAP WITH ICP MONITORING ACCESS PORT?

The FDA 510(k) record lists Integra Neurocare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHUNT TAP WITH ICP MONITORING ACCESS PORT?

The FDA product code for SHUNT TAP WITH ICP MONITORING ACCESS PORT is JXG.

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Other records listing Integra Neurocare, LLC as applicant

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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.