Home / 510(k) Clearances / K242034

510(k) K242034

Duet External Drainage and Monitoring System (EDMS) by Medtronic Neurosurgery — Product Code PCB

K242034 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "Duet External Drainage and Monitoring System (EDMS)". The FDA issued a decision of Substantially Equivalent on October 24, 2024. The device falls under product code PCB (External Cerebrospinal Fluid (Csf) Diversion), a Class II device regulated under 21 CFR 882.5560. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2024
Date Received
July 11, 2024
Clearance Type
Special
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.

Other clearances by Medtronic Neurosurgery

  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K212641 — StrataMR II Valves and Shunts (September 16, 2021)
  • K181622 — StrataMR guider tool (October 1, 2018)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
  • K152700 — StrataMR Valves and Shunts (April 7, 2016)
  • DEN120017 — Medtronic DUET External Drainage and Monitoring System (August 22, 2014)
  • K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (February 13, 2013)
  • K110560 — MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER (November 18, 2011)
  • K091312 — PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (September 2, 2009)
  • K083076 — STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 4 (November 20, 2008)

Other clearances for product code PCB

  • DEN120017 — Medtronic DUET External Drainage and Monitoring System (August 22, 2014)

FDA data resources