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510(k) K261541

VisionAir Enhanced Stock Stent by VisionAir Solutions — Product Code NWA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 1, 2026
Date Received: May 8, 2026
Clearance Type: Special
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.