NHC — Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) Class II
FDA product code NHC covers "Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)", a Class II medical device regulated under 21 CFR 882.4100. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHC
- Device Class
- Class II
- Regulation Number
- 882.4100
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Definition
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K160223 | cook incorporated | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impr | April 8, 2016 |
| K071640 | cook | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM | July 12, 2007 |
| K011812 | cook | SPECTRUM VENTRICULAR CATHETER | November 8, 2001 |