Data / Medical devices / External Cerebrospinal Fluid (Csf) Diversion
External Cerebrospinal Fluid (Csf) Diversion (PCB): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make External Cerebrospinal Fluid (Csf) Diversion (product code PCB, Class 2, 21 CFR 882.5560). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on October 24, 2024, and lists 1 recall event (1 Class I). FDA data exported November 2, 2026.
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- Product code
- PCB
- Device class
- 2
- Regulation
- 882.5560
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| Mexico | 1 |
| United States | 1 |
| Malaysia | 1 |
Makers of External Cerebrospinal Fluid (Csf) Diversion
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 2 | October 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 2 | October 24, 2024 | 0 | 1 | 1 | api.fda.gov |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.