K250592
- 510(k) number
- K250592
- Device name
- NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
- Applicant
- Northeast Scientific, Inc. CT · US
- Product code
- OWQ — Reprocessed Intravascular Ultrasound Catheter
- Decision date
- 2025-05-12
- Date received
- 2025-02-27
- 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: K250592.pdf
Official FDA record: K250592
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.