Data / Medical devices / United States / VisionAir Solutions
VisionAir Solutions: FDA-registered device maker in Akron, OH, United States, 1 510(k) clearance
VisionAir Solutions is registered with the FDA (registration 3010197296) in Akron, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010197296
- Address
- 1800 Triplett Blvd, Akron, OH, United States, 44306
- Owner or operator
- Theken Companies, LLC (10050903)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 9, 2023
- Registered through
- 2026
- Brand names listed
- VisionAir 3D Stent, VisionAir 3D Stent Architect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Tracheal, Preformed/Molded | NWA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2022 | K213969 | VisionAir Patient-Specific Airway Stent | NWA | Substantially Equivalent | New Cos Inc. Dba Visionair Solutions | accessdata.fda.gov |
Compare with other makers
Updated October 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.