K250545
- 510(k) number
- K250545
- Device name
- Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
- Applicant
- Surgical Instrument Service and Savings, Inc. OR · US
- Product code
- OWQ — Reprocessed Intravascular Ultrasound Catheter
- Decision date
- 2025-06-05
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250545.pdf
Official FDA record: K250545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.