PCB
- Product code
- PCB
- Device name
- External Cerebrospinal Fluid (Csf) Diversion
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242034 | 2024-10-24 | Medtronic Neurosurgery | Duet External Drainage and Monitoring System (EDMS) |
Official FDA classification page: PCB
Classification and pathway per current FDA publications. Data from openFDA (CC0).