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Trapper Exchange Device

by Creganna Medical Aslo Business AS Cregganna Tactx Medical

510(k) K162253

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) K162253↗

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 NumberK162253 Date6 Jan 2017ClearedStatusActive
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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Trapper Exchange Device is a cardiovascular medical device classified under product code DQY, designed for use in percutaneous coronary interventions. It is intended for the exchange of guidewires and catheters within coronary arteries, facilitating procedural efficiency during coronary angiography or percutaneous transluminal coronary angioplasty (PTCA).

This device is supplied as a single-use, non-sterile instrument and is intended for use in clinical settings such as cardiac catheterization laboratories. It is regulated under the FDA 510(k) pathway with a clearance date of January 6, 2017, and complies with the Medical Device Directive (MDD). No specific MRI safety information is provided, and its dimensions or additional technical specifications are not detailed in the available data.

Other devices from Creganna Medical Aslo Business AS Cregganna Tactx Medical

Questions

AI-generated answers, 20 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 purpose of the Trapper Exchange Device in a cardiac procedure?

    The Trapper Exchange Device is specifically designed to streamline the exchange of guidewires and catheters during percutaneous coronary interventions, such as coronary angiography or PTCA. Its use helps improve procedural efficiency by reducing the time and complexity involved in switching tools within coronary arteries.

  • Is the Trapper Exchange Device intended for reuse, or is it meant to be used only once?

    The Trapper Exchange Device is explicitly supplied as a single-use instrument, meaning it is intended for one-time clinical use only. This design choice aligns with common practices for reducing infection risks in sterile environments like cardiac catheterization labs.

  • How is the Trapper Exchange Device regulated, and what pathway was used for its approval?

    The Trapper Exchange Device was cleared through the FDA 510(k) pathway, specifically under the Traditional review process, with a clearance date of January 6, 2017. It is also compliant with the Medical Device Directive (MDD). The device falls under product code DQY, which categorizes it for use in cardiovascular procedures.

  • Is the Trapper Exchange Device sterile when supplied, and where is it intended for use?

    The Trapper Exchange Device is supplied in a non-sterile state, meaning it requires sterilization or preparation by the clinical staff before use. It is intended for use in clinical settings such as cardiac catheterization laboratories, where procedures like coronary angiography or PTCA are performed.

  • Does the Trapper Exchange Device have any known compatibility or safety information regarding MRI use?

    The available data does not provide any specific MRI safety information for the Trapper Exchange Device. Clinicians should exercise caution and verify compatibility with their MRI systems before use, as no details on magnetic field interactions or safety in MRI environments are included.