PCB · Class II · 21 CFR 882.5560

External Cerebrospinal Fluid (csf) Diversion — FDA 510(k) Devices

Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion.

1
Total
1
Cleared
105d
Avg days
2024
Since

List of External Cerebrospinal Fluid (csf) Diversion devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034
Medtronic Neurosurgery
Neurology · 105d

How to use this database

This page lists all FDA 510(k) submissions for External Cerebrospinal Fluid (csf) Diversion devices (product code PCB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →