FDA 510(k)

VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V

K-Number: K002392 · 2000-11-02

Decision Date2000-11-02

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V 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 2000-11-02 under 510(k) number K002392. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V?

VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V is a medical device that received FDA 510(k) clearance on 2000-11-02. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K002392.

When did VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V receive FDA 510(k) clearance?

VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V received FDA 510(k) clearance on 2000-11-02, under 510(k) number K002392.

Who is the listed applicant for VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V?

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 VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V?

The FDA product code for VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V is GWM.

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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.