Cleared Traditional

K160514 - OptiCross 18

K160514 is the FDA 510(k) clearance for OptiCross 18 by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code OBJ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K160514 · Boston Scientific Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2016
Decision
119d
Days
Class 2
Risk

K160514 is an FDA 510(k) clearance for the OptiCross 18, 30 MHz Peripheral Imaging Catheter. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Fremont, US). The FDA issued a Cleared decision on June 22, 2016 after a review of 119 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K160514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2016
Decision Date June 22, 2016
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
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 62
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K160514.
AcuNav V 10F Ultrasound Catheter
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AcuNav Volume ICE Catheter
K163478 · Siemens Medical Solutions USA, Inc. · Feb 2017
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
K160583 · Volcano Corporation · Oct 2016
OptiCross X, 40 MHz Coronary Imaging Catheter
K161125 · Boston Scientific Corporation · May 2016
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
Visions PV .035 Digital IVUS Catheter
K153094 · Volcano Corporation · Dec 2015