JOWIRE ASAHI PTCA CATHETER GUIDE WIRES - 14M350

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

510(k) Number

K031277 ↗

FDA Product Code

DQX

Models / Variants

AG145300

141300

142300

132200

14M350

14M345

14M360

143390

141002

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

  Class II

  FDA 510(k) K022762 Active Cleared 16 Dec 2002

• Smartwire/Smartmap Pressure System

  Class II

  FDA 510(k) K021219 Active Cleared 17 May 2002

• In-Vision Imaging System

  Class II

  FDA 510(k) K031148 Active Cleared 28 May 2003

• Fox PTA Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 Mm, Models A14003, A14004, A14005, A14006, A14007, A14008

  Class II

  FDA 510(k) K010838 Active Cleared 21 Jun 2001

• Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900

  Class II

  FDA 510(k) K031346 Active Cleared 23 Jun 2003

• Modification to Fox PTA Catheter

  Class II

  FDA 510(k) K020854 Active Cleared 11 Apr 2002

See all devices from Jomed AG →

• What specific clinical procedure are these guide wires designed to assist with, and why is their tip design important?

  These guide wires are designed to assist in the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), a procedure used to open narrowed coronary arteries. The atraumatic-tipped design ensures minimal risk of vessel damage during navigation through complex coronary anatomy, which is critical for safe and effective angioplasty.

• Are these guide wires reusable, or are they intended for single-use only? How does this affect their handling?

  These guide wires are intended for single-use only and are supplied sterile. This design choice reduces infection risks and ensures consistent performance, requiring clinicians to follow strict sterile procedures during use and dispose of them after a single procedure.

• What distinguishes the different models (e.g., AG145300 vs. 14M350) of these guide wires, and how might a clinician choose between them?

  Each model is differentiated by its reference code, which likely corresponds to variations in length, tip flexibility, or core construction (e.g., torque performance or tip durability). While the exact specifications aren’t detailed here, the composite core design suggests these variations may optimize navigation for different coronary anatomies or procedural needs. Clinicians would select a model based on procedural requirements, such as vessel tortuosity or lesion complexity.

• Can these guide wires be used in an MRI environment, and if not, what precautions should be taken?

  No, these guide wires are not MRI-compatible. If MRI imaging is required post-procedure, the wires must be removed from the patient first, as metallic components could interfere with MRI fields or pose safety risks during scanning.

• What storage conditions should be followed to maintain the sterility and performance of these guide wires?

  Since they are supplied sterile, they should be stored in their original packaging until use, protected from contamination, moisture, and extreme temperatures. Avoid exposure to direct sunlight or mechanical damage, as this could compromise sterility or structural integrity before use.