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510(k) DEN120017

Medtronic DUET External Drainage and Monitoring System by Medtronic Neurosurgery — Product Code PCB

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 22, 2014
Date Received
December 21, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Cerebrospinal Fluid (Csf) Diversion
Device Class
Class II
Regulation Number
882.5560
Review Panel
NE
Submission Type

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

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Other clearances for product code PCB

  • K242034 — Duet External Drainage and Monitoring System (EDMS) (October 24, 2024)