Home / Device Classification / PCB

PCB — External Cerebrospinal Fluid (Csf) Diversion Class II

FDA Device Classification

Classification Details

Product Code
PCB
Device Class
Class II
Regulation Number
882.5560
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242034medtronic neurosurgeryDuet External Drainage and Monitoring System (EDMS)October 24, 2024
DEN120017medtronic neurosurgeryMedtronic DUET External Drainage and Monitoring SystemAugust 22, 2014