VisionAir Patient-Specific Airway Stent
FDA 510(k) clearance K213969 · decided 2022-10-07
Clearance details
- K-number
- K213969
- Device name
- VisionAir Patient-Specific Airway Stent
- Applicant
- New Cos Inc. Dba Visionair Solutions
- Decision
- Substantially Equivalent
- Date received
- 2021-12-20
- Decision date
- 2022-10-07
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- NWA
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VisionAir Enhanced Stock Stent (K261541) | VisionAir Solutions | 2026-06-01 |
| TRACHEOBRONXANE™ DUMON® (K243126) | Novatech SA | 2024-10-29 |
| Patient-Specific Airway Stent (K182743) | New Cos, Inc. | 2019-10-23 |
| ENDOXANE (K971509) | Novatech SA | 1997-08-21 |
| DUMON TRACHEOBRONCHIAL STENT (K894380) | Bryan Corp. | 1989-10-24 |
| HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES (K873742) | Hood Laboratories | 1987-10-01 |
Recalls involving this device
No recalls on record reference this clearance.