Home / 510(k) Clearances / K213969

510(k) K213969

VisionAir Patient-Specific Airway Stent by New Cos Inc. Dba Visionair Solutions — Product Code NWA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 7, 2022
Date Received: December 20, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Tracheal, Preformed/Molded
Device Class: Class II
Regulation Number: 878.3720
Review Panel: AN
Submission Type

The device is intended to provide support to weakened or constricting airway walls.