K233904
- 510(k) number
- K233904
- Device name
- ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- Applicant
- Acist Medical Systems, Inc. MN · US
- Product code
- DXO — Transducer, Pressure, Catheter Tip
- Decision date
- 2024-07-17
- Date received
- 2023-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233904.pdf
Official FDA record: K233904
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.