K233904 is an FDA 510(k) clearance for the ACIST RXi System (016616). This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 17, 2024, 219 days after receiving the submission on December 11, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K233904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2023 |
| Decision Date | July 17, 2024 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXO - Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |