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) → HCA — Catheter, Ventricular

# HCA · Catheter, Ventricular

_Neurology · 21 CFR 882.4100 · Class 2_

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

## Overview

- **Product Code:** HCA
- **Device Name:** Catheter, Ventricular
- **Regulation:** [21 CFR 882.4100](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4100)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** 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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K161731](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K161731.md) | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | Mar 27, 2017 | SESE |
| [K123605](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K123605.md) | SMARTFLOW CATHETER | Mri Interventions, Inc. | Aug 16, 2013 | SESE |
| [K031123](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K031123.md) | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | Codman & Shurtleff, Inc. | May 14, 2003 | SESE |
| [K021481](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K021481.md) | BRESAGEN CATHETER, MODEL CS-3000 | Bresagen, Inc. | Aug 6, 2002 | SESE |
| [K020728](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K020728.md) | MIETHKE SHUNT SYSTEM | Aesculap, Inc. | Apr 5, 2002 | SESE |
| [K013005](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K013005.md) | ACT 11 MP VENTRICULAR CATHETER | Innerspace, Inc. | Mar 8, 2002 | SESE |
| [K003322](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K003322.md) | CODMAN BACTISEAL CATHETERS | Codman & Shurtleff, Inc. | Oct 1, 2001 | SESE |
| [K992796](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K992796.md) | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | Image-Guided Neurologics, Inc. | Oct 25, 1999 | SESE |
| [K983331](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K983331.md) | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | Medtronic PS Medical | Dec 16, 1998 | SESE |
| [K834477](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HCA/K834477.md) | DISPOS. SCOTT CANNULAS 16-1054 ETC. | Codman & Shurtleff, Inc. | Mar 19, 1984 | SESE |

## Top Applicants

- Codman & Shurtleff, Inc. — 3 clearances
- Aesculap, Inc. — 1 clearance
- Bresagen, Inc. — 1 clearance
- Image-Guided Neurologics, Inc. — 1 clearance
- Innerspace, Inc. — 1 clearance

---

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

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