Cleared Traditional

Artimes pro Balloon Dilatation Catheter (K203390) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K203390 · Brosmed Medical Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2021
Decision
147d
Days
Class 2
Risk

K203390 is an FDA 510(k) clearance for the Artimes pro Balloon Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Brosmed Medical Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on April 14, 2021 after a review of 147 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 Co., Ltd. devices

Submission Details

510(k) Number K203390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2020
Decision Date April 14, 2021
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Eminence Clinical Research, Inc.
Diane Horwitz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03301246 Completed Interventional Industry-sponsored

Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease

Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease

60
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Coronary Artery Disease; Heart Disease, Ischemic; Coronary Stenosis
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jasvinder Singh, MD
Sponsor Eminence Clinical Research, Inc. (industry)
Started 2018-10-31 → Primary completion 2020-01-29 → Completed 2020-05-08
Primary outcome
Procedure Success
Secondary outcome
Anticipated Adverse Events
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 43
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K203390.
Selethru(TM) NC PTCA Balloon Dilatation Catheter
K211393 · Kossel Medtech (Suzhou) Co., Ltd. · Jul 2021
KardiFlex NC Coronary Dilatation Catheter
K202578 · Medcaptain Life Science Co., Ltd. · May 2021
KardiFlex PTCA Balloon Dilatation Catheter
K202619 · Medcaptain Life Science Co., Ltd. · Apr 2021
Sapphire II PRO
K200269 · Orbusneich Medical Trading, Inc. · Mar 2020
Sapphire NC Plus Coronary Dilatation Catheter
K192344 · Orbusneich Medical Trading, Inc. · Sep 2019
Selethru PTCA Balloon Dilatation Catheter
K182699 · Kossel Medtech (Suzhou) Co., Ltd. · Nov 2018