Cleared Traditional

K140273 - EQUALIZER OCCLUSION BALLOON CATHETER

K140273 is the FDA 510(k) clearance for EQUALIZER OCCLUSION BALLOON CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K140273 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
169d
Days
Class 2
Risk

K140273 is an FDA 510(k) clearance for the EQUALIZER OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on July 22, 2014 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Corp devices

Submission Details

510(k) Number K140273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date July 22, 2014
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 27
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K140273.
Sniper Infusion Catheter with Balloon Occlusion
K180904 · Embolx, Inc. · Jun 2018
GORE Molding and Occlusion Balloon Catheter
K172567 · W. L. Gore and Associates, Inc. · Jan 2018
Fogarty Occlusion Catheter
K152762 · Edwards Lifesciences, LLC · Nov 2015
OCCLUSION BALLOON CATHETER
K132990 · Boston Scientific Corp · Oct 2013
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MicroVention, Inc. · Aug 2012
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698 · MicroVention, Inc. · Jan 2012