The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Exalt Model B Single-use Bronchoscope.
| Device ID | K222014 |
| 510k Number | K222014 |
| Device Name: | EXALT Model B Single-Use Bronchoscope |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Carter Navarro |
| Correspondent | Carter Navarro Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-08 |
| Decision Date | 2022-07-28 |