FDA 510(k) Applications Submitted by IRRAS USA Inc.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K231664 | 06/07/2023 | IRRAflow Active Fluid Exchange System (AFES) | IRRAS USA Inc. |
| K200807 | 03/27/2020 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | IRRAS USA Inc. |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact