K242034
- 510(k) number
- K242034
- Device name
- Duet External Drainage and Monitoring System (EDMS)
- Applicant
- Medtronic Neurosurgery TX · US
- Product code
- PCB — External Cerebrospinal Fluid (Csf) Diversion
- Decision date
- 2024-10-24
- Date received
- 2024-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242034.pdf
Official FDA record: K242034
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.