DEN120017 is an FDA 510(k) submission for the Medtronic DUET External Drainage and Monitoring System. This device is classified as a External Cerebrospinal Fluid (csf) Diversion (Class II - Special Controls, product code PCB).
Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Not Cleared (DENG) decision on August 22, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5560. Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion..
| 510(k) Number | DEN120017 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 21, 2012 |
| Decision Date | August 22, 2014 |
| Days to Decision | 609 days |
| Submission Type | Post-NSE |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | PCB — External Cerebrospinal Fluid (csf) Diversion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5560 |
| Definition | Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion. |