FDA.reportPublic FDA data

VisionAir Solutions

Matched from indexed company URL: VisionAir Solutions, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101972963010197296VisionAir Solutions1N2026-01-011800 Triplett Blvd Akron OH US 44306

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860011822608VisionAir 3D Stent - The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.2168005905info@visionairsolutions.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3222531162788442K213969VisionAir Patient-Specific Airway StentNWA2022-10-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NWA12022-10-07

GUDID#

VisionAir 3D Stent - The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.

VisionAir Solutions, LLC

2024-05-01