FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VisionAir Patient-Specific Airway Stent
K Number: K213969
·
Decision Oct 7, 2022
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
1
Review Days
291
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Basic Information
- Device Name
- VisionAir Patient-Specific Airway Stent
- K Number
- K213969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3720
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- New Cos Inc. Dba Visionair Solutions
- Date Received
- December 20, 2021
- Decision Date
- October 7, 2022
- Product Code
- NWA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NWA | Prosthesis, Tracheal, Preformed/Molded | FDA class 2 | General, Plastic Surgery |
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