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510(k) K243676

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2025
Date Received
November 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Medtronic Neurosurgery

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  • 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 JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (August 20, 2024)
  • K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ve (January 17, 2024)