Skip to content

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

by BrosMed Medical Co., Ltd.

510(k) K160941

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160941↗

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 NumberK160941 Date13 Dec 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-0963-2019 FDA Class II initiated 14 Dec 2018

    Incorrect (higher) Rated Burst Pressure information printed on label.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD 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 Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is a catheter, angioplasty, peripheral, transluminal designed for percutaneous transluminal angioplasty (PTA). It is intended to dilate narrowed or occluded peripheral arteries by inflating a balloon within the lumen to restore blood flow.

This device is supplied as a single-use, non-compliant (NC) balloon catheter and is classified as Class II under FDA regulations (870.1250). It is intended for use in interventional radiology or cardiology settings, with available sizes and models referenced in the registration data. The device holds FDA 510(k) clearance, MDD, and MDR authorisations, ensuring compliance with regulatory standards for peripheral vascular interventions.

Other devices from BrosMed Medical Co., Ltd.

See all devices from BrosMed Medical Co., Ltd. →

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 settings is this balloon catheter designed for use in, and why is this important for clinicians?

    The Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is specifically designed for use in interventional radiology or cardiology settings, where peripheral vascular interventions are performed. This matters for clinicians because it ensures the device is optimized for procedures targeting narrowed or occluded arteries in these specialized environments, where precise dilation of blood vessels is critical for restoring blood flow.

  • Is this device reusable, or is it intended for single-use only? How does this affect its handling and storage?

    This device is intended for single-use only, as explicitly stated in the product description. This means it must be discarded after one procedure to maintain sterility and safety. Clinicians should follow manufacturer guidelines for proper handling, storage in a clean, dry environment, and adherence to expiration dates to ensure optimal performance and compliance with medical protocols.

  • What regulatory pathways does this device follow, and what does that mean for its compliance and use?

    The Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter holds FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means the device has undergone rigorous review by regulatory bodies to confirm its safety and effectiveness for its intended use—percutaneous transluminal angioplasty (PTA)—and meets international standards for peripheral vascular interventions. Clinicians can rely on this regulatory backing to ensure the device adheres to established medical guidelines.

  • What sizes and models are available for this catheter, and how might this impact procedure selection?

    The device comes in multiple sizes and models, as indicated by the extensive list of registration numbers (e.g., 3011471056, 3011142981, etc.) under the product code LIT. These variations allow clinicians to select the appropriate catheter diameter and length for different patient anatomies and vascular conditions, ensuring a tailored approach to dilation. The manufacturer’s documentation should specify exact measurements, but the availability of diverse options supports flexibility in treating a wide range of peripheral arterial occlusions.

  • How is the sterility of this device maintained, and what precautions should be taken during use?

    Since the Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is a single-use device, sterility is maintained through proper packaging and handling per manufacturer instructions. Clinicians must ensure the catheter remains unopened until immediate use, avoid contamination during setup, and follow aseptic techniques to prevent infection. Discarding the device post-procedure is critical to uphold sterility standards and reduce cross-contamination risks in clinical settings.