510(k) K242034
- Device
- Duet External Drainage and Monitoring System (EDMS)
- Applicant
- Medtronic Neurosurgery
- 510(k) number
- K242034
- Product code
- PCB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-24
- Date received
- 2024-07-11
- Regulation
- 882.5560
- Classification name
- External Cerebrospinal Fluid (Csf) Diversion
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Foram Shukla
- Address
- 4620 N Beach St. Fort Worth TX US 76137 76137
FDA Registration Numbers#
- 3004593495
- 9617601
- 3018094310
- 2032112
- 3015531529
Source Documents#
Other 510(k) Records For Product Code PCB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN120017 | Medtronic DUET External Drainage and Monitoring System | Medtronic Neurosurgery | 2014-08-22 |