K233270
- 510(k) number
- K233270
- Device name
- AcuNav Crystal Ultrasound Catheter
- Applicant
- Siemens Medical Solutions USA, Inc. WA · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2023-10-28
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K233270.pdf
Official FDA record: K233270
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.