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Vascular Guide Wire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913353

by Advanced Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K913353 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vascular Guide Wire is classified as a vascular catheter under FDA product code DQX, designed for use in coronary and peripheral vascular procedures. It functions as a flexible, steerable tool to navigate through blood vessels, facilitating the placement of catheters, balloons, or stents during angioplasty or other interventional cardiology techniques. Its structure allows for precise manipulation within tortuous anatomy, reducing trauma to vessel walls while providing mechanical support during interventions. The device is intended for diagnostic and therapeutic applications within the cardiovascular system.

This guide wire is supplied as a single-use, non-sterile device and requires sterilization prior to use, typically via ethylene oxide or gamma irradiation. It is intended for use in MRI-compatible settings, though its specific MRI safety classification (e.g., MRI Conditional or Safe) is not detailed in the submission. The device is regulated under FDA 510(k) clearance (K913353) and falls under the Cardiovascular (CV) advisory committee review. No third-party review or additional regulatory markings are referenced in the available data.

Frequently asked questions

What is the Vascular Guide Wire designed for?

The Vascular Guide Wire is specifically engineered for use in coronary and peripheral vascular procedures. It serves as a flexible, steerable tool to navigate through blood vessels, enabling the precise placement of catheters, balloons, or stents during angioplasty or other interventional cardiology techniques. Its design minimizes trauma to vessel walls while providing mechanical support during interventions, making it suitable for both diagnostic and therapeutic cardiovascular applications.

Is the Vascular Guide Wire single-use or reusable?

The Vascular Guide Wire is supplied as a single-use device. It is not intended for reuse and must be sterilized prior to use, typically via methods such as ethylene oxide or gamma irradiation, to ensure safety and efficacy.

What sterilization methods are recommended for this device?

The device requires sterilization before use, and the most common methods referenced are ethylene oxide or gamma irradiation. These methods are standard for preparing single-use medical devices to ensure they are free from contamination prior to clinical application.

Can this guide wire be used in MRI-compatible settings?

The Vascular Guide Wire is intended for use in MRI-compatible settings, though the specific MRI safety classification (such as MRI Conditional or Safe) is not detailed in the available data. Clinicians should verify compatibility with their MRI system and follow facility protocols to ensure safe use.

What regulatory pathway does this device follow?

The Vascular Guide Wire is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K913353. It falls under the Cardiovascular (CV) advisory committee review and is classified as substantially equivalent to a predicate device. No third-party review or additional regulatory markings are referenced in the available data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VASCULAR GUIDE WIRE (K913353) — FDA 510 (k) | Innolitics, PDF K913353 VASCULAR GUIDE WIRE - 510kdatabase.net, Vascular Guide Wire 510 (k) FDA Premarket Notification K913353 ADVANCED ..., Advanced Cardiovascular Systems, Inc. FDA 510(k) Products (1982-2002), MRI compatible guide wire - Advanced Cardiovascular Systems, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Cardiovascular Systems, Inc.

Sources (1)

  • FDA 510(k) K913353 24 fields · synced Oct 1, 2026