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Artimes Pro Balloon Dilatation Catheter

by BrosMed Medical Co., Ltd.

510(k) K203390

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203390↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK203390 Date14 Apr 2021ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LOX
Device Class
Class II
Regulation
21 CFR Part 870.5100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Artimes Pro Balloon Dilatation Catheter is a Transluminal Coronary Angioplasty, Percutaneous device, classified as a Class II medical device. It is designed for the dilation of coronary arteries to restore blood flow in patients with obstructive coronary artery disease, facilitating complex coronary interventions through its semi-compliant, rapid-exchange balloon technology.

This catheter is supplied as a single-use, non-sterile device (sterilized prior to use) and is intended for use in cardiac catheterization laboratories. It is MRI-unsafe due to its metallic components and must be handled with care to avoid contamination. Available in various sizes, it requires proper storage in a clean, dry environment to maintain integrity. Authorized under FDA 510(k) clearance (K203390) and the Medical Device Directive (MDD), it adheres to regulatory standards for cardiovascular intervention devices.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical purpose of the Artimes pro Balloon Dilatation Catheter and how does its design support this use?

    The Artimes pro Balloon Dilatation Catheter is specifically designed for transluminal coronary angioplasty, a procedure to dilate narrowed or obstructed coronary arteries and restore blood flow in patients with obstructive coronary artery disease. Its semi-compliant, rapid-exchange balloon technology allows for precise dilation during complex coronary interventions, reducing the risk of vessel damage while ensuring effective treatment of blockages.

  • Is the Artimes pro Balloon Dilatation Catheter intended for single-use or repeated use, and how should it be prepared before use?

    The device is single-use only and is supplied in a non-sterile state. It must be sterilized prior to use in a cardiac catheterization laboratory setting, following manufacturer guidelines to ensure sterility and safety before deployment. This design minimizes contamination risks during procedures.

  • What storage conditions are required to maintain the integrity of the Artimes pro Balloon Dilatation Catheter?

    The catheter must be stored in a clean, dry environment to preserve its structural integrity and functionality. Since it contains metallic components, it should be kept away from sources of moisture, extreme temperatures, or physical damage to avoid compromising performance or sterility before use.

  • Are there any safety considerations related to MRI compatibility or handling for the Artimes pro Balloon Dilatation Catheter?

    The catheter is MRI-unsafe due to its metallic components, meaning it should never be used or stored in an MRI environment. Additionally, care must be taken during handling to prevent contamination, as it is intended for single-use in sterile cardiac catheterization procedures.

  • What regulatory pathways has the Artimes pro Balloon Dilatation Catheter followed, and what does this mean for its use?

    The device has been authorized through FDA 510(k) clearance (K203390) and compliance with the Medical Device Directive (MDD). This means it has undergone evaluation by regulatory authorities to demonstrate substantial equivalence to legally marketed predicate devices, ensuring it meets safety and performance standards for Class II cardiovascular intervention devices as defined by FDA regulations.