Evolve Nitric Oxide Delivery System— 510(k) K222930

Substantially Equivalent

Mallinckrodt Manufacturing, LLC

FDA 510(k) clearance K222930 for Evolve Nitric Oxide Delivery System, Substantially Equivalent on 2023-12-06. Applicant: Mallinckrodt Manufacturing, LLC.

Clearance details

Applicant: Mallinckrodt Manufacturing, LLC
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2022-09-26
Decision date: 2023-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.