VisionAir Patient-Specific Airway Stent— 510(k) K213969

Name: FDA 510(k) clearance K213969
Creator: U.S. Food and Drug Administration
Published: 2022-10-07

Substantially Equivalent

New Cos Inc. Dba Visionair Solutions

FDA 510(k) clearance K213969 for VisionAir Patient-Specific Airway Stent, Substantially Equivalent on 2022-10-07. Applicant: New Cos Inc. Dba Visionair Solutions. Device class: 2.

Clearance details

Applicant: New Cos Inc. Dba Visionair Solutions
Product code: Code NWA
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 2021-12-20
Decision date: 2022-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.