Artemis Neuro Evacuation Device— 510(k) K171332
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K171332 for Artemis Neuro Evacuation Device, Substantially Equivalent on 2017-08-14. Applicant: Penumbra, Inc..
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Code GWG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Adverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
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.