Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter— 510(k) K230928

Name: FDA 510(k) clearance K230928
Creator: U.S. Food and Drug Administration
Published: 2023-08-25

Substantially Equivalent

Vein 360, LLC

FDA 510(k) clearance K230928 for Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter, Substantially Equivalent on 2023-08-25. Applicant: Vein 360, LLC. Device class: 2.

Clearance details

Applicant: Vein 360, LLC
Product code: Code OWQ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2023-04-03
Decision date: 2023-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Ash, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.