510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120017Unknown

Medtronic DUET External Drainage and Monitoring System

Medtronic Neurosurgery, Goleta CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN120017 is the FDA 510(k) clearance record for Medtronic DUET External Drainage and Monitoring System, a class II device, cleared for Medtronic Neurosurgery on under FDA product code PCB (External Cerebrospinal Fluid (Csf) Diversion). FDA's definition for product code PCB reads: "Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion". FDA records list 28 510(k) clearances for Medtronic Neurosurgery, from to . As of , FDA records show no recalls naming DEN120017.

Clearance record

Decision date
Received
(609 days to decision)
Product code
PCB External Cerebrospinal Fluid (Csf) Diversion
Regulation
21 CFR 882.5560
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Neurosurgery 125 Cremona Dr., Goleta CA
Third party review
No

Clearances, product code PCB

Trailing 12 months

FDA records hold no clearances under product code PCB in the trailing twelve months.

FDA records show no clearances under product code PCB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260