PCB

External Cerebrospinal Fluid (Csf) Diversion

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-10-24.

NumberDecision dateApplicantDevice nameSummary
K2420342024-10-24Medtronic NeurosurgeryDuet External Drainage and Monitoring System (EDMS)PDF

1 summaries are archived here for direct download.

Official FDA classification page: PCB
Classification and pathway per current FDA publications. Data from openFDA (CC0).