510(k) DEN120017
- Device
- Medtronic DUET External Drainage and Monitoring System
- Applicant
- Medtronic Neurosurgery
- 510(k) number
- DEN120017
- Product code
- PCB
- Decision
- Unknown (DENG)
- Decision date
- 2014-08-22
- Date received
- 2012-12-21
- Regulation
- 882.5560
- Classification name
- External Cerebrospinal Fluid (Csf) Diversion
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- DONOVAN MAY
- Address
- 125 Cremona Dr. Goleta CA US 93117 93117
FDA Registration Numbers#
- 9617601
- 3015531529
- 2032112
- 3018094310
- 3004593495
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PCB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242034 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2024-10-24 |