PCB
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- External Cerebrospinal Fluid (Csf) Diversion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5560
- Medical specialty
- Neurology
- FDA definition
- Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Duet External Drainage and Monitoring System (EDMS) (K242034) | Medtronic Neurosurgery | 2024-10-24 |
| Medtronic DUET External Drainage and Monitoring System (DEN120017) | Medtronic Neurosurgery | 2014-08-22 |
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Every clearance here is in the API, with alerts when new ones post.