K232584
- 510(k) number
- K232584
- Device name
- Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
- Applicant
- Vein 360, LLC OH · US
- Product code
- OWQ — Reprocessed Intravascular Ultrasound Catheter
- Decision date
- 2023-10-24
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232584.pdf
Official FDA record: K232584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.