21 CFR 882.4100 — Catheter, Ventricular
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4100
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HCA | Catheter, Ventricular | 2 | 10 | 3rd Party |
| NHC | Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) | 2 | 3 | Implant |
| PVM | Endoscopic Ventricular Catheter Placement Kit | 2 | 0 |
