Cleared Traditional

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (K230584) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230584 · Vein 360, LLC · Cardiovascular device
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Jun 2023
Decision
96d
Days
Class 2
Risk

K230584 is an FDA 510(k) clearance for the Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Vein 360, LLC (Blue Ash, US). The FDA issued a Cleared decision on June 6, 2023 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vein 360, LLC devices

Submission Details

510(k) Number K230584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2023
Decision Date June 06, 2023
Days to Decision 96 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OWQ Reprocessed Intravascular Ultrasound Catheter

All 18
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K230584.
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
K230928 · Vein 360, LLC · Aug 2023
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
K231621 · Stryker Sustainability Solutions · Jul 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · Abbott Medical · Jun 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · Abbott Medical · May 2023
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · Northeast Scientific, Inc. · Feb 2023
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · Abbott Medical · Dec 2022