The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Exalt Model D Single-use Duodenoscope, Exalt Controller.
| Device ID | K193202 |
| 510k Number | K193202 |
| Device Name: | EXALT Model D Single-Use Duodenoscope, EXALT Controller |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Carter Navarro |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-20 |
| Decision Date | 2019-12-13 |
| Summary: | summary |