PCB — External Cerebrospinal Fluid (Csf) Diversion Class II
FDA product code PCB covers "External Cerebrospinal Fluid (Csf) Diversion", a Class II medical device regulated under 21 CFR 882.5560. Submissions are reviewed by the Neurology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PCB
- Device Class
- Class II
- Regulation Number
- 882.5560
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.