# K242034: Duet External Drainage and Monitoring System (EDMS)

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Oct 24, 2024 after 105 days
- Product code: PCB (External Cerebrospinal Fluid (Csf) Diversion)
- Device class: 2
- Regulation: 21 CFR 882.5560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN120017 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120017: Medtronic DUET External Drainage and Monitoring System, Medtronic Neurosurgery (2014) Summary page 5.

## Indications for use
The DUET EDMS is indicated for temporary draining and monitoring of cerebrospinal fluid (CSF) flow from the lumbar subarachnoid space in: 1. Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery. 2. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

Source page: https://510kreport.com/device/K242034
Methodology: https://510kreport.com/methodology