EVOLVE Nitric Oxide Delivery System— 510(k) K240410
Substantially EquivalentMalinckrodt Manufacturing, LLC
FDA 510(k) clearance K240410 for EVOLVE Nitric Oxide Delivery System, Substantially Equivalent on 2024-05-28. Applicant: Malinckrodt Manufacturing, LLC.
Clearance details
- Applicant
- Malinckrodt Manufacturing, LLC
- Product code
- Code MRN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Madison, WI, US
Adverse events under product code MRN
product code MRN- Death
- 9
- Malfunction
- 910
- Total
- 919
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.