K251231
- 510(k) number
- K251231
- Device name
- ViewFlex X ICE Catheter, Sensor Enabled
- Applicant
- ABBOTT MEDICAL CA · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2025-05-20
- Date received
- 2025-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K251231.pdf
Official FDA record: K251231
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.