Asahi PTCA Guide Wire, Fielder J, Model AGP140000J, AGP140300J

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K062186

Identifiers

510(k) Number: K062186 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 J, is a coronary guidewire designed for use in percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). It assists in the precise placement of balloon dilation catheters within coronary arteries, facilitating revascularization procedures.

This device is supplied as a single-use, non-sterile product and is intended for use in controlled clinical settings such as cardiac catheterization laboratories. It is regulated under FDA 510(k) clearance (K062186) and the Medical Device Directive (MDD), with no third-party involvement. Models AGP140000J and AGP140300J are the specified variants, each identified by unique reference codes.

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: FIELDER® | Asahi Intecc Medical, Asahi Ptca Guide Wire, Fielder J, Model Agp140000j, Agp140300j (K062186 ..., Fielder | Medical products for Coronary | ASAHI INTECC PRODUCTS, K062186 - ASAHI PTCA GUIDE WIRE | FDA 510 (k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K062186	Class II	Active

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Manufacturer

Manufacturer: Asahi Intecc Co., Ltd.

Sources (2)

FDA 510(k) K062186 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026