K232584 is an FDA 510(k) clearance for the 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. This device is classified as a Reprocessed Intravascular Ultrasound Catheter (Class II - Special Controls, product code OWQ).
Submitted by Vein 360, LLC (Blue Ash, US). The FDA issued a Cleared decision on October 24, 2023, 60 days after receiving the submission on August 25, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology..
| 510(k) Number | K232584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2023 |
| Decision Date | October 24, 2023 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OWQ - Reprocessed Intravascular Ultrasound Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |