Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4100](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4100) → NHC — Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

# NHC · Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

_Neurology · 21 CFR 882.4100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NHC

## Overview

- **Product Code:** NHC
- **Device Name:** Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
- **Regulation:** [21 CFR 882.4100](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4100)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K160223](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NHC/K160223.md) | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | Cook Incorporated | Apr 8, 2016 | SESE |
| [K071640](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NHC/K071640.md) | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM | Cook, Inc. | Jul 12, 2007 | SESE |
| [K011812](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NHC/K011812.md) | SPECTRUM VENTRICULAR CATHETER | Cook, Inc. | Nov 8, 2001 | SESE |

## Top Applicants

- Cook, Inc. — 2 clearances
- Cook Incorporated — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NHC](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/NHC)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
