FDA 510(k)

INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER

K-Number: K121159 · 2012-07-20

ApplicantIntegra Lifescience Corportation

Decision Date2012-07-20

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifescience Corportation. It received FDA 510(k) clearance on 2012-07-20 under 510(k) number K121159. 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 INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER?

INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is Integra Lifescience Corportation. The 510(k) number is K121159.

When did INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER receive FDA 510(k) clearance?

INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER received FDA 510(k) clearance on 2012-07-20, under 510(k) number K121159.

Who is the listed applicant for INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER?

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

What is the FDA product code for INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER?

The FDA product code for INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER is GWM.

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Official Source

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