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Asahi PTCA Guide Wire, Fielder FC J (Models: AGP140001J, AGP140301J)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K072705

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K072705 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 Asahi PTCA Guide Wire, Fielder FC J, is a coronary guidewire designed for use in percutaneous transluminal coronary angioplasty (PTCA). It is classified as a coronary guidewire, a device used to navigate through blood vessels to facilitate the placement of catheters or balloons during coronary interventions.

This guidewire is supplied sterile and intended for single-use. It is regulated under the FDA’s 510(k) pathway with a Special clearance under the Cardiovascular advisory committee, and complies with the Medical Device Directive (MDD). The models AGP140001J and AGP140301J are intended for use in interventional cardiology settings, with appropriate handling and storage to maintain sterility.

Frequently asked questions

What are the two model numbers for the Asahi PTCA Guide Wire, Fielder FC J, and how do they differ in their intended use?

The Asahi PTCA Guide Wire, Fielder FC J, comes in two models: AGP140001J and AGP140301J. Both are designed for coronary guidewire applications in percutaneous transluminal coronary angioplasty (PTCA) to assist with catheter or balloon placement during coronary interventions. While the exact technical differences between the two models are not specified in the data, they are both intended for use in interventional cardiology settings and share the same regulatory pathway and sterility standards.

Is the Asahi PTCA Guide Wire, Fielder FC J, reusable, or is it meant for single-use only?

The Asahi PTCA Guide Wire, Fielder FC J, is intended for single-use only. This is explicitly stated in the device description, emphasizing the need for appropriate handling and storage to maintain sterility, which is critical for single-use medical devices.

How is the Asahi PTCA Guide Wire, Fielder FC J, supplied, and what does that mean for its storage?

The Asahi PTCA Guide Wire, Fielder FC J, is supplied sterile, meaning it is packaged and sterilized by the manufacturer to ensure it is free from contaminants before use. This requires careful storage to preserve sterility—typically in a sealed, sterile barrier system—until the time of use, as per standard medical device handling protocols.

What regulatory pathways does the Asahi PTCA Guide Wire, Fielder FC J, follow, and how does that affect its use?

The Asahi PTCA Guide Wire, Fielder FC J, is regulated under the FDA’s 510(k) pathway with a Special clearance through the Cardiovascular advisory committee, and it also complies with the Medical Device Directive (MDD). This means its safety and performance were compared to a legally marketed predicate device (substantially equivalent) and reviewed by the FDA’s Cardiovascular panel before clearance. Clinicians and buyers can rely on this regulatory route as evidence of its compliance with U.S. and EU standards for coronary guidewires.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (2)

  • FDA 510(k) K072705 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 28, 2026