Skip to content

Codman Microsensor Ventricular Catheter Kit

by Johnson & Johnson Professionals, Inc.

510(k) K991222

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991222 Date9 Jul 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWM
Device Class
Class II
Regulation
21 CFR Part 882.1620
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Codman Microsensor Ventricular Catheter Kit is a triple-lumen catheter system designed for intracranial pressure monitoring and cerebrospinal fluid drainage. It features an embedded sensor, a preloaded stylet for insertion, a Y-connector for drainage system attachment, a suture clip, and a tunneling trocar with tubing.

This device is intended for clinical use in a neurological setting. It has received FDA 510(k) clearance under the regulation number 882.1620.

Other devices from Johnson & Johnson Professionals, Inc.

See all devices from Johnson & Johnson Professionals, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Codman Microsensor Ventricular Catheter Kit?

    This device is a triple-lumen catheter system specifically designed for clinical use in neurological settings to perform intracranial pressure monitoring and facilitate cerebrospinal fluid drainage.

  • What components are included in the catheter kit?

    The kit is supplied as a comprehensive system containing an embedded sensor, a preloaded stylet to assist with insertion, a Y-connector for attaching drainage systems, a suture clip, and a tunneling trocar with tubing.

  • What is the regulatory status of this device?

    The Codman Microsensor Ventricular Catheter Kit has received FDA 510(k) clearance under regulation number 882.1620, which classifies it as a device for intracranial pressure monitoring.