Emprint Ablation Visualization Application— 510(k) K180192
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K180192 for Emprint Ablation Visualization Application, Substantially Equivalent on 2018-03-21. Applicant: Covidien, LLC.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.