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FDA 510(k)

VisionAir Patient-Specific Airway Stent

K-Number: K213969 · 2022-10-07

Decision Date2022-10-07
Product CodeNWA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NWA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.