Vein 360, LLC · Class II · Cleared Oct 24, 2023
| 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 |
| Product code | OWQ |
| Device class | Class II |
| Decision date | Oct 24, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 870.1200 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov