Cleared Traditional

K141025 - ARTIMES BALLOON DILATATION CATHETER

K141025 is an FDA 510(k) clearance for ARTIMES BALLOON DILATATION CATHETER, manufactured by Brosmed Medical. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K141025 · Brosmed Medical · Cardiovascular device
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Sep 2014
Decision
144d
Days
Class 2
Risk

K141025 is an FDA 510(k) clearance for the ARTIMES BALLOON DILATATION CATHETER. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Brosmed Medical (Dongguan, Guangdong, CN). The FDA issued a Cleared decision on September 12, 2014 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 Brosmed Medical devices

FDA 510(k) Submission Details - K141025

510(k) Number K141025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2014
Decision Date September 12, 2014
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOX Device Classification - Class 2, Special Controls

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 52
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K141025.
Pantera Pro
K160985 · Biotronik, Inc. · Oct 2016
NC Quantum Apex PTCA Dilatation Catheter
K160823 · Boston Scientific Corporation · Jun 2016
Euphora Rapid Exchange Balloon Dilatation Catheter
K143480 · Medtronic, Inc. · Apr 2015
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
K141090 · Medtronic, Inc. · Aug 2014
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K141236 · Boston Scientific Corporation · Aug 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
K134031 · Boston Scientific Corporation · Jul 2014