510(k) K213969
- Device
- VisionAir Patient-Specific Airway Stent
- Applicant
- New COS Inc. DBA VisionAir Solutions
- 510(k) number
- K213969
- Product code
- NWA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-07
- Date received
- 2021-12-20
- Regulation
- 878.3720
- Classification name
- Prosthesis, Tracheal, Preformed/molded
- Medical specialty
- General & Plastic Surgery
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Keith Grafmeyer
- Address
- 7100 Euclid Ave. Suite 180 Cleveland OH US 44103 44103
FDA Registration Numbers#
- 9613846
- 1220850
- 3010197296
Source Documents#
Other 510(k) Records For Product Code NWA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243126 | TRACHEOBRONXANE™ DUMON® | Novatech SA | 2024-10-29 |
| K182743 | Patient-Specific Airway Stent | New Cos, Inc. | 2019-10-23 |
| K971509 | ENDOXANE | Novatech SA | 1997-08-21 |
| K894380 | DUMON TRACHEOBRONCHIAL STENT | Bryan Corp. | 1989-10-24 |
| K873742 | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | Hood Laboratories | 1987-10-01 |
Legacy Summary#
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FDA Review#
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