Cleared Traditional

K183679 - Occlusion Balloon Catheter

K183679 is the FDA 510(k) clearance for Occlusion Balloon Catheter by Qxmedical, LLC. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K183679 · Qxmedical, LLC · Cardiovascular device
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Apr 2019
Decision
117d
Days
Class 2
Risk

K183679 is an FDA 510(k) clearance for the Occlusion Balloon Catheter. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Qxmedical, LLC (Saint Paul, US). The FDA issued a Cleared decision on April 24, 2019 after a review of 117 days - within the typical 510(k) review window.

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 Qxmedical, LLC devices

Submission Details

510(k) Number K183679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2018
Decision Date April 24, 2019
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
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 42
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K183679.
ER-REBOA PLUS Catheter
K193440 · Prytime Medical Devices, Inc. · Jan 2020
RenovoCath
K191606 · Renovorx, Inc. · Aug 2019
Eclipse 2L
K183045 · Balt USA, LLC · Apr 2019
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
K182916 · Lemaitre Vascular · Nov 2018
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