K250955
- 510(k) number
- K250955
- Device name
- XC11 ICE System, USA
- Applicant
- Yorlabs, Inc. CA · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2025-10-22
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250955.pdf
Official FDA record: K250955
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.