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Microslider Tearaway Introducer Set

by Galt Medical Corp.

510(k) K123430

Active European Union and United States

CE MDR 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) K123430↗

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 NumberK123430 Date12 Apr 2013ClearedStatusActive
European UnionCE/MDR 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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
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 Microslider Tearaway Introducer Set is a vascular introducer system designed for percutaneous vascular access procedures. It facilitates the insertion of catheters or guidewires into blood vessels, particularly in smaller or challenging access sites, by providing a controlled pathway for device introduction while minimizing trauma to the vessel wall.

This set is intended for single-use in clinical settings such as cardiac catheterization labs, interventional radiology, or emergency departments. Supplied sterile and packaged for aseptic use, it includes components compatible with MRI environments as specified by the manufacturer. The device is authorized under FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for medical 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 types of clinical settings is the Microslider Tearaway Introducer Set designed for, and why is this important for my procedure planning?

    The Microslider Tearaway Introducer Set is specifically designed for use in clinical settings like cardiac catheterization labs, interventional radiology, and emergency departments. This is important because these environments require precise vascular access, often in smaller or more challenging sites, where minimizing vessel trauma is critical. The set’s design supports controlled catheter or guidewire insertion, reducing complications during procedures.

  • Is the Microslider Tearaway Introducer Set reusable, or is it intended for single-use only? How does this affect its clinical utility?

    The Microslider Tearaway Introducer Set is explicitly intended for single-use only, as stated in the manufacturer’s description. This design choice ensures sterility and reduces the risk of cross-contamination between patients, which is particularly important in sterile environments like catheterization labs or interventional radiology. Single-use also simplifies inventory management and disposal protocols.

  • What makes the Microslider Tearaway Introducer Set compatible with MRI environments, and why might this be relevant for my patients?

    The set is explicitly noted as compatible with MRI environments, meaning its materials and construction do not interfere with magnetic resonance imaging. This is relevant if your patients require post-procedure MRI scans, as the introducer’s components will not pose risks like artifacts or heating during imaging. This feature expands its utility in hybrid or multi-modality care settings.

  • How is the Microslider Tearaway Introducer Set packaged, and what does this imply about its handling and preparation for use?

    The device is supplied sterile and packaged for aseptic use, which means it arrives pre-sterilized and sealed to maintain sterility until opened. This packaging ensures that clinicians can immediately prepare the set for use without additional sterilization steps, reducing procedural time and minimizing exposure to contamination risks. The tear-away design also implies ease of access to components during the procedure.