Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
The Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agent) (product code NHC) is a neurology device used to access the cerebral ventricles for drainage of cerebrospinal fluid or injection of therapeutic agents, incorporating an antibiotic or antimicrobial coating or impregnation to reduce the risk of catheter-related infections, as described in its definition. It is classified as an FDA Class 2 device within the Neurology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device carries an implant designation.
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Basic Information
- Product Code
- NHC
- Device Class
- FDA class 2
- Regulation Number
- 882.4100
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | Apr 08, 2016 | Substantially Equivalent | Cook Incorporated |
| K071640 | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM | Jul 12, 2007 | Substantially Equivalent | Cook, Inc. |
| K011812 | SPECTRUM VENTRICULAR CATHETER | Nov 08, 2001 | Substantially Equivalent | Cook, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.