K233948
- 510(k) number
- K233948
- Device name
- Provisio SLT IVUS System
- Applicant
- Provisio Medical, Inc. CA · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2024-04-23
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233948.pdf
Official FDA record: K233948
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.