The following data is part of a premarket notification filed by Drw Medical with the FDA for Exsalta.
| Device ID | K221676 |
| 510k Number | K221676 |
| Device Name: | Exsalta |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | DRW Medical 2710 Concord Road Aston, PA 19104 |
| Contact | Dan Tatum |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-09 |
| Decision Date | 2022-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EXSALTA 98124091 not registered Live/Pending |
DRW Medical LLC 2023-08-09 |