Cleared Traditional

K143613 - PaxWire Occlusion Balloon System

K143613 is an FDA 510(k) clearance for PaxWire Occlusion Balloon System, manufactured by Accessclosure, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K143613 · Accessclosure, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
238d
Days
Class 2
Risk

K143613 is an FDA 510(k) clearance for the PaxWire Occlusion Balloon System. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Accessclosure, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 14, 2015 after a review of 238 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.

FDA 510(k) Submission Details - K143613

510(k) Number K143613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2014
Decision Date August 14, 2015
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K143613.
Pruitt F3-S Polyurethane Carotid Shunt
K152833 · LeMaitre Vascular, Inc. · Jan 2016
Fogarty Occlusion Catheter
K152762 · Edwards Lifesciences, LLC · Nov 2015
Pruitt F3-S Carotid Shunt
K143454 · LeMaitre Vascular, Inc. · Aug 2015
Occlusion Balloon Catheter
K142692 · Embolx, Inc. · May 2015
RENOVOCATH RC120
K141175 · Renovorx, Inc. · Oct 2014
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · Boston Scientific Corp · Jul 2014
K143613 · PaxWire Occlusion Balloon System
Download PDF FDA Summary Accessclosure, Inc.