← Product Code [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG) · K962097

# VENTRICULAR CATHETER SET (K962097)

_Cook, Inc. · JXG · Aug 29, 1996 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K962097

## Device Facts

- **Applicant:** Cook, Inc.
- **Product Code:** [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG.md)
- **Decision Date:** Aug 29, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5550
- **Device Class:** Class 2
- **Review Panel:** Neurology
- **Attributes:** Therapeutic

## Indications for Use

The Ventricular Catheter Set is used to obtain access to a ventricular cavity of the brain to drain fluid externally for the purpose of relieving elevated intracranial pressure or fluid volume.

## Device Story

Ventricular catheter set; provides access to brain ventricular cavity; enables external drainage of cerebrospinal fluid; relieves elevated intracranial pressure or fluid volume; used in clinical settings; sterile; single-use; physician-operated.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Catheter for CNS fluid drainage; materials have established history of medical use; supplied sterile; single-use; physical dimensions and design consistent with standard ventricular catheters.

## Regulatory Identification

A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

## Submission Summary (Full Text)

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510(k) Premarket Notification
Ventricular Catheter Set
K962097
Page 12
AUG 29 1996

I.510(K) SUMMARY

Submitted By:

April Lavender
COOK INCORPORATED
925 South Curry Pike
P.O. Box 489
Bloomington, IN 47402
(812) 339-2235
May 24, 1996

Device:

Trade Name: Ventricular Catheter Set
Common/Usual Name: Ventricular Catheter, External
Drainage Catheter
Proposed Classification: Central Nervous System Fluid Shunt
and Components
21 CFR 882.5550 (84JXG)

Predicate Devices:

The Ventricular Catheter Set is similar in terms of intended
use, materials of construction, and technological
characteristics to predicate ventricular catheters which
have been reviewed as central nervous system fluid shunt
devices.

Device Description:

The Ventricular Catheter Set is used to obtain access to a
ventricular cavity of the brain to drain fluid externally
for the purpose of relieving elevated intracranial pressure
or fluid volume. The device is supplied sterile and is
intended for one-time use. The materials comprising the
device have an established history of use in medical product
manufacturing.

Substantial Equivalence:

The device will be manufactured according to specified
process controls and a Quality Assurance Program, undergoing
packaging and sterilization procedures similar to devices
currently manufactured and marketed by COOK INCORPORATED.
This device is similar with respect to indications for use,
materials and physical characteristics to predicate devices
in terms of section 510(k) substantial equivalency.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K962097](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K962097)

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