NHC · Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Neurology · 21 CFR 882.4100 · Class 2
Overview
| Product Code | NHC |
|---|---|
| Device Name | Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) |
| Regulation | 21 CFR 882.4100 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | Cook Incorporated | Apr 8, 2016 | SESE |
| K071640 | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM | Cook, Inc. | Jul 12, 2007 | SESE |
| K011812 | SPECTRUM VENTRICULAR CATHETER | Cook, Inc. | Nov 8, 2001 | SESE |
Top Applicants
- Cook, Inc. — 2 clearances
- Cook Incorporated — 1 clearance
