510(k) K242034— Duet External Drainage and Monitoring System (EDMS)
Substantially EquivalentMedtronic Neurosurgery
Clearance details
- Applicant
- Medtronic Neurosurgery
- Product code
- Code PCB
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fort Worth, TX, US
Adverse events under product code PCB
product code PCB- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.