Submission Details
| 510(k) Number | K230928 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 03, 2023 |
| Decision Date | August 25, 2023 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
Aug 2023
Decision
144d
Days
Class 2
Risk
About This 510(k) Submission
K230928 is an FDA 510(k) clearance for the Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter, 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 August 25, 2023, 144 days after receiving the submission on April 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| 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. |
Manufacturer
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