Who is the manufacturer of VENTRICULAR CATHETER SET?

Cook, Inc. filed the 510(k) submission for VENTRICULAR CATHETER SET (K962097).

What is the FDA product code for VENTRICULAR CATHETER SET?

JXG. It is classified under 21 CFR 882.5550 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for VENTRICULAR CATHETER SET?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VENTRICULAR CATHETER SET?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VENTRICULAR CATHETER SET

K962097 · Cook, Inc. · JXG · Aug 29, 1996 · Neurology

Device Facts

Record ID	K962097
Device Name	VENTRICULAR CATHETER SET
Applicant	Cook, Inc.
Product Code	JXG · Neurology
Decision Date	Aug 29, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5550
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Indications for Use

Indicated for patients requiring external drainage of cerebrospinal fluid to relieve elevated intracranial pressure or fluid volume.

Regulatory Classification

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.

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K022638 — NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT · Neurorecovery, Inc. · Oct 31, 2002
K021481 — BRESAGEN CATHETER, MODEL CS-3000 · Bresagen, Inc. · Aug 6, 2002
K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM · Radionics, Inc. · Aug 4, 2000
K090348 — CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET · Codman & Shurtleff, Inc. · Mar 4, 2009

Submission Summary (Full Text)

{0} 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.