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
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
| 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
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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510(k) Summary PDF or remain unpublished.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