K240050
- 510(k) number
- K240050
- Device name
- SOUNDSTAR CRYSTAL Ultrasound Catheter
- Applicant
- Biosense Webster, Inc. CA · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2024-06-12
- Date received
- 2024-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K240050.pdf
Official FDA record: K240050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.