# DEN120017: Medtronic DUET External Drainage and Monitoring System

- Pathway: De Novo (Post-NSE)
- Applicant: Medtronic Neurosurgery
- Decided: Aug 22, 2014 after 609 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K242034: Duet External Drainage and Monitoring System (EDMS) (2024), 0 descendants of its own

## Indications for use
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, and 2) patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

Source page: https://510kreport.com/device/DEN120017
Methodology: https://510kreport.com/methodology