Cleared Traditional

CODMAN MICROSENSOR VENTRICULAR CATHETER KIT

K991222 · Johnson & Johnson Professionals, Inc. · Neurology
Jul 1999
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K991222 is an FDA 510(k) clearance for the CODMAN MICROSENSOR VENTRICULAR CATHETER KIT, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on July 9, 1999, 88 days after receiving the submission on April 12, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K991222 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1999
Decision Date July 09, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

Similar Devices — GWM Device, Monitoring, Intracranial Pressure

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