Clearance Summary
Medtronic DUET External Drainage and Monitoring System received FDA 510(k) clearance under submission number DEN120017, sponsored by Medtronic Neurosurgery. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-08-22.
- Submission: DEN120017
- Applicant / Sponsor: Medtronic Neurosurgery
- Clearance pathway: Post-NSE
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5560
- Decision date: 2014-08-22
Classification & Regulation
This clearance is catalogued under FDA product code PCB and 21 CFR 882.5560, within the Neurology review panel as a Class II device.