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Polux, Minerva and Atropos PTA Balloon Dilatation Catheter

by BrosMed Medical Co., Ltd.

510(k) K160256

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160256↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK160256 Date29 Jul 2016ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
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 Polux, Minerva and Atropos PTA Balloon Dilatation Catheter is a catheter, angioplasty, peripheral, transluminal designed for percutaneous transluminal angioplasty (PTA). This device is used to dilate narrowed or occluded arteries in peripheral vascular systems, improving blood flow through the affected vessels by mechanically expanding the lumen via an inflatable balloon.

These catheters are supplied as single-use, sterile medical devices and are intended for use in interventional radiology or cardiology settings. They are classified as Class II devices under FDA regulations (870.1250) and have received FDA 510K clearance, MDD, and MDR authorisations. Available in multiple sizes and reference codes, they must be stored according to manufacturer instructions to maintain sterility and functionality before use.

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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 clinical scenarios is the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheter designed to address?

    This catheter is specifically designed for percutaneous transluminal angioplasty (PTA) to mechanically expand narrowed or occluded arteries in the peripheral vascular system. It improves blood flow by dilating vessels affected by stenosis or blockages, commonly used in interventional radiology or cardiology settings for treating peripheral arterial disease.

  • Are these catheters reusable, or are they intended for single-use only?

    The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters are explicitly supplied as single-use, sterile devices. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

  • How should these catheters be stored to maintain their sterility and functionality?

    The manufacturer provides specific storage instructions to preserve sterility and functionality. While the exact details are not listed here, standard practice for single-use, sterile medical devices like these requires storage in a sealed, protective packaging away from moisture, extreme temperatures, and direct sunlight. Always follow the manufacturer’s instructions included with the product.

  • What regulatory pathways have these catheters undergone, and which committees were involved?

    The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters have undergone FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. The FDA submission was reviewed by the Cardiovascular (CV) Advisory Committee under the Traditional 510(k) pathway, with a decision code of SESE (Substantially Equivalent). The product falls under FDA classification 870.1250 and OpenFDA’s product code LIT for peripheral angioplasty catheters.