Cleared Traditional

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

K232584 · Vein 360, LLC · Cardiovascular

Oct 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K232584 FDA.gov
FDA Decision	Cleared 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

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.