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VisionAir 3D Stent

FDA UDI

Class II (US FDA UDI)

by VisionAir Solutions

Identity

Trade Name
VisionAir 3D Stent FDA UDI
Generic Name
Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
Device Name
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. FDA UDI
Model / Reference
1 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
0010-0126 FDA UDI
Primary DI / UDI-DI
00860011822608 FDA UDI
510(k) Number
K213969 FDA UDI
FDA Product Code
NWA FDA UDI
GMDN Term
Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Polymeric tracheal/bronchial stent, non-bioabsorbable

VisionAir 3D Stent by VisionAir Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric tracheal/bronchial stent, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
VisionAir Solutions

Sources (1)

  • FDA UDI 37e39507-6052-4773-8154-a97e8a9f7f7e 37 fields · synced Jun 8, 2026