Skip to content

WireClip Torquer

by Boston Scientific Corporation Northwest Technology

510(k) K003398

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) K003398↗

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 · Special NumberK003398 Date1 Dec 2000ClearedStatusActive
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  • Withdrawn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
DQX
Device Class
Class II
Regulation
21 CFR Part 870.1330
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 WireClip Torquer is a Cardiovascular Device designed to apply controlled torque to guidewire clips, facilitating secure attachment and detachment during percutaneous coronary interventions. It is classified under product code DQX and is intended for use with guidewires in coronary procedures, ensuring precise manipulation of wire positioning within coronary arteries.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as cardiac catheterization labs. It requires no sterility beyond standard surgical cleaning protocols and is not MRI-safe. The model number H802221960030 is the designated identifier for this version. Authorized under FDA 510(k) clearance (K003398) and MDR compliance, it adheres to regulatory standards for cardiovascular tools.

Other devices from Boston Scientific Corporation Northwest Technology

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 purpose of the WireClip Torquer in a cardiac catheterization lab?

    The WireClip Torquer is specifically designed to apply controlled torque to guidewire clips during percutaneous coronary interventions. This ensures precise and secure attachment and detachment of guidewires within coronary arteries, helping clinicians maintain accurate wire positioning for procedures like stent placement or angioplasty.

  • Is the WireClip Torquer intended for single-use or reusable applications, and what cleaning requirements apply?

    The WireClip Torquer is a reusable medical instrument, meaning it is designed for repeated use in clinical settings like cardiac catheterization labs. It does not require sterile packaging beyond standard surgical cleaning protocols, which must be followed to maintain its functionality and safety for subsequent procedures.

  • What model number identifies this version of the WireClip Torquer, and how can I verify its regulatory compliance?

    This version of the WireClip Torquer is identified by the model number H802221960030. It is authorized under FDA 510(k) clearance (K003398) and MDR compliance, ensuring it meets regulatory standards for cardiovascular tools. The clearance type is classified as *Special*, and it falls under the Cardiovascular (CV) advisory committee for submissions.

  • Can this device be used in an MRI environment, and what are its key physical specifications?

    The WireClip Torquer is not MRI-safe, meaning it should not be used in magnetic resonance imaging environments due to potential interference or safety risks. While the provided data does not specify exact torque measurements or physical dimensions, it is designed as a reusable instrument for controlled torque application on guidewire clips in coronary procedures, adhering to product code DQX for cardiovascular tools.