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External CSF Drainage Ventricular and Lumbar Catheters

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K242974

by Sophysa

Identifiers

510(k) Number
K242974 FDA 510(k)
FDA Product Code
JXG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5550 FDA 510(k)
Regulation Number
882.5550 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

These devices are external cerebrospinal fluid (CSF) drainage catheters designed for ventricular and lumbar placement. They facilitate the controlled removal of excess CSF from the central nervous system to relieve pressure in conditions such as hydrocephalus or post-neurosurgical bleeding.

The catheters are supplied sterile and intended for single-use. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Directive (MDD). Sizes and configurations vary by model, and proper handling requires adherence to sterile techniques in clinical settings. Authorisations include FDA 510(k) clearance and MDD compliance, ensuring adherence to regulatory standards for neurological drainage applications.

Frequently asked questions

Are these catheters reusable or intended for single-use only, and how should they be handled to maintain sterility?

These catheters are explicitly designed for single-use only and are supplied in a sterile condition. To maintain sterility, they must be handled using strict aseptic techniques, including keeping the sterile packaging intact until immediate use and avoiding contamination during placement. Reuse is not recommended or supported by the manufacturer.

What types of drainage sites do these catheters support, and how do they differ in application?

Sophysa’s catheters are available in two primary configurations: ventricular and lumbar placement. Ventricular catheters drain cerebrospinal fluid (CSF) from the brain’s ventricular system, while lumbar catheters target the lower spinal region. The choice depends on the clinical condition—ventricular catheters are typically used for hydrocephalus or post-neurosurgical bleeding, whereas lumbar catheters may be preferred for localized CSF pressure relief.

How are these devices regulated, and what does the FDA’s 510(k) clearance indicate about their safety and performance?

These catheters hold FDA 510(k) clearance, meaning they have been determined to be substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. The clearance was granted under the Neurology advisory committee and follows a traditional review process, ensuring compliance with FDA regulations for Class II medical devices. Compliance with the Medical Device Directive (MDD) further confirms adherence to European regulatory standards.

Do these catheters come in multiple sizes or models, and how might a clinician determine the appropriate selection?

Yes, the catheters are available in various sizes and configurations to accommodate different patient anatomies and clinical needs. The manufacturer provides specific models for ventricular and lumbar drainage, and the selection should be based on the intended placement site, patient-specific anatomy, and the clinical protocol. Detailed sizing guidance is typically included in the product documentation or can be confirmed with the manufacturer’s technical support.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sophysa

Sources (2)

  • FDA 510(k) K242974 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026