Duet External Drainage and Monitoring System (EDMS)
FDA 510(k) clearance K242034 · decided 2024-10-24
Clearance details
- K-number
- K242034
- Device name
- Duet External Drainage and Monitoring System (EDMS)
- Applicant
- Medtronic Neurosurgery
- Decision
- Substantially Equivalent
- Date received
- 2024-07-11
- Decision date
- 2024-10-24
- Days to decision
- 105 days
- Clearance type
- Special
- Product code
- PCB
- Device class
- 2
- Regulation number
- 882.5560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Medtronic DUET External Drainage and Monitoring System (DEN120017) | Medtronic Neurosurgery | 2014-08-22 |
Recalls involving this device
No recalls on record reference this clearance.