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VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter

by Cook Incorporated

510(k) K160223

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK160223 Date8 Apr 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NHC
Device Class
Class II
Regulation
21 CFR Part 882.4100
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and the VentriClear II Ventricular Drainage Catheter are ventricular drainage catheters designed to obtain access to a ventricular cavity of the brain for short-term use. The device is used to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume. It is classified as a Class II medical device under regulation number 882.4100 for catheters, ventricular, containing antibiotic or antimicrobial agents.

The device is supplied as a set and is intended for single-use in clinical settings where external ventricular drainage is required. It features antibiotic impregnation for enhanced patient safety during short-term drainage procedures. Storage conditions and handling instructions are detailed in the manufacturer's labeling. The device is authorized through an FDA 510(k) premarket notification under K160223, with a substantially equivalent determination, and is reviewed under the Neurology advisory committee.

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Questions

AI-generated answers, 25 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 VentriClear II used for?

    The VentriClear II is a ventricular drainage catheter designed to access the brain’s ventricular cavity for short-term external drainage of fluid. It is used to relieve elevated intracranial pressure by draining excess cerebrospinal fluid in clinical environments.

  • How is the device supplied?

    The device is supplied as a complete catheter set, including all necessary components for ventricular drainage. It is intended for single use and is packaged for sterile presentation in clinical settings.

  • Is the device sterile and single-use?

    Yes, the VentriClear II is supplied as a single-use device and is intended for sterile presentation. It is not designed for reuse, and any reprocessing would compromise sterility and device integrity.

  • What sizes or models are available?

    The VentriClear II is available as a specific catheter set model with Cook Spectrum antibiotic impregnation. Detailed sizing and configuration options are provided in the manufacturer’s labeling and surgical technique documentation.

  • How should the device be stored?

    Storage conditions and handling instructions are detailed in the manufacturer’s labeling. The device should be stored in a dry, controlled environment prior to use to maintain sterility and packaging integrity.