VisionAir Solutions

FDA Device Registration & Listing · Akron, OH, US · Registration 3010197296

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010197296
FEI Number
3010197296
Entity Name
VisionAir Solutions
City/State/Country
Akron, OH, US
Establishment Address
1800 Triplett Blvd, Akron, OH 44306, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Theken Companies, LLC (Owner Number: 10050903)
Owner / Operator Contact Address
1800 Triplett Blvd, Akron, OH 44306, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213969
PMA Number
N/A

All Registered Proprietary Names

VisionAir 3D Stent Architect VisionAir 3D Stent

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NWA Prosthesis, Tracheal, Preformed/Molded General, Plastic Surgery Class 2 878.3720 2023-11-09

Official Correspondent

Garrett Spurgeon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Theken Companies, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3002498892 THEKEN COMPANIES, LLC Akron, OH, US

Similar Registrations

Registration Number Establishment Name Location
1220850 E. Benson Hood Laboratories, Inc. Pembroke, MA, US
9613846 NOVATECH S.A. LA CIOTAT CEDEX Bouches-du-Rhone, FR
3028606342 OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD Guangzhou Guangdong, CN
3038274470 BRAINMATTERZ, INC McKinney, TX, US
3012404174 LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL. Schio Vicenza, IT
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010197296. Last updated year: 2026. Please use registration number 3010197296 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.