Guide Wire Extension

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K915114 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Diagnostic Intravascular Catheter

  Class II

  FDA 510(k) K925813 Active Cleared 23 Mar 1994

• Angiographic Catheter

  Class II

  FDA 510(k) K926243 Active Cleared 16 Aug 1993

• Retriever II

  Class II

  FDA 510(k) K964210 Active Cleared 31 Oct 1997

• Infusion Catheter W/Side Holes

  Class II

  FDA 510(k) K854000 Active Cleared 5 Nov 1985

• Guide Wire Introducer

  Class II

  FDA 510(k) K873972 Active Cleared 1 Apr 1988

• Turbo Tracker

  Class II

  FDA 510(k) K960806 Active Cleared 2 May 1996

See all devices from Target Therapeutics →

• What is the Guide Wire Extension (DQX) used for in interventional cardiology?

  The Guide Wire Extension (DQX) is designed to extend the length of a standard guide wire during coronary procedures. Its primary purpose is to help navigate through challenging vascular anatomy, such as tortuous or occluded coronary arteries, where standard guide wires may fall short. By providing additional reach, it enables continued use of established catheter-based techniques without compromising the primary guide wire’s functionality, thereby improving procedural success.

• How is the Guide Wire Extension supplied and prepared for use?

  The Guide Wire Extension is supplied as a single-use, non-sterile item. It requires manual assembly with a compatible guide wire before use. This means clinicians must attach it to an existing guide wire in a controlled clinical environment, such as a cardiac catheterization lab, prior to performing the procedure. The non-sterile nature emphasizes the need for proper aseptic techniques during assembly and use.

• Is the Guide Wire Extension compatible with all guide wire systems?

  The Guide Wire Extension is specifically designed to maintain compatibility with existing guide wire systems commonly used in interventional cardiology. While it is intended to work with standard systems, compatibility should always be verified with the manufacturer’s instructions or technical specifications for the specific guide wire being used. This ensures seamless integration and avoids potential procedural complications.

• What storage instructions should be followed for the Guide Wire Extension?

  Storage instructions for the Guide Wire Extension should adhere strictly to the manufacturer’s guidelines provided in the accompanying documentation. While no additional sterility or regulatory markings beyond the FDA clearance are specified, proper storage conditions are critical to preserve the device’s functionality and integrity. This typically includes protection from moisture, extreme temperatures, and physical damage, ensuring it remains effective when needed for clinical use.

• Can the Guide Wire Extension be reused or is it intended for single-use only?

  The Guide Wire Extension is explicitly intended for single-use only. This design choice aligns with clinical best practices to minimize infection risks and ensure consistent performance. Reusing the extension could compromise sterility, integrity, and safety, which is why it is not recommended. Clinicians should adhere to single-use protocols to maintain procedural standards and patient safety.