FDA 510(k)

VisionAir Patient-Specific Airway Stent

Numéro K : K213969 · 2022-10-07

DemandeurNew Cos Inc. Dba Visionair Solutions

Date de décision2022-10-07

Code produitNWA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

VisionAir Patient-Specific Airway Stent is the device name listed in this FDA 510(k) record. The listed applicant is New Cos Inc. Dba Visionair Solutions. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K213969. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the VisionAir Patient-Specific Airway Stent?

VisionAir Patient-Specific Airway Stent is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is New Cos Inc. Dba Visionair Solutions. The 510(k) number is K213969.

When did VisionAir Patient-Specific Airway Stent receive FDA 510(k) clearance?

VisionAir Patient-Specific Airway Stent received FDA 510(k) clearance on 2022-10-07, under 510(k) number K213969.

Who is the listed applicant for VisionAir Patient-Specific Airway Stent?

The FDA 510(k) record lists New Cos Inc. Dba Visionair Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VisionAir Patient-Specific Airway Stent?

The FDA product code for VisionAir Patient-Specific Airway Stent is NWA.

Essais cliniques associés

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Dispositifs connexes (Code : NWA)

K261541VisionAir Enhanced Stock StentVisionAir Solutions K243126TRACHEOBRONXANE™ DUMON®Novatech SA K182743Patient-Specific Airway StentNew Cos, Inc.

Source officielle

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