K241540
- 510(k) number
- K241540
- Device name
- NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter
- Applicant
- Biosense Webster, Inc. CA · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2024-06-28
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241540.pdf
Official FDA record: K241540
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.