Cleared Traditional

K150442 - Volcano Visions PV .018 Digital IVUS Ca...

K150442 is the FDA 510(k) clearance for Volcano Visions PV .018 Digital IVUS Ca... by Volcano Corporation. It is a Class 2 Cardiovascular device (product code OBJ) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K150442 · Volcano Corporation · Cardiovascular device
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Sep 2015
Decision
196d
Days
Class 2
Risk

K150442 is an FDA 510(k) clearance for the Volcano Visions PV .018 Digital IVUS Catheter. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on September 4, 2015 after a review of 196 days - an extended review cycle.

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 Volcano Corporation devices

Submission Details

510(k) Number K150442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date September 04, 2015
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
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 - OBJ Catheter, Ultrasound, Intravascular

All 61
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K150442.
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
K153617 · Boston Scientific Corporation · Feb 2016
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K153094 · Volcano Corporation · Dec 2015
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K152829 · Volcano Corporation · Nov 2015
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
K143701 · Volcano Corporation · Aug 2015
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
K123621 · Boston Scientific Corp · Apr 2013
VISIONS PV .035 DITITAL IVUS CATHETER
K121273 · Volcano Corporation · Sep 2012