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Asahi PTCA Guide Wire Asahi SION Series

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191464

by Asahi Intecc Co., Ltd.

Identifiers

510(k) Number
K191464 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 Asahi SION Series is a percutaneous transluminal coronary angioplasty (PTCA) guide wire, designed to assist in the precise placement of balloon dilation catheters within coronary arteries. Its proprietary Composite Core SION TECC construction enhances tip flexibility and durability, improving navigability through complex coronary anatomy while maintaining torque response for stable advancement.

This guide wire is supplied as a single-use, non-sterile device, intended for use in interventional cardiology procedures. It is regulated under FDA 510(k) clearance (K191464) and falls under the DQX product code for vascular intervention devices. Proper handling and storage per manufacturer instructions are required to ensure performance integrity, with no specific MRI safety restrictions noted in the available data.

Frequently asked questions

What is the Asahi PTCA Guide Wire Asahi SION Series specifically designed to improve during coronary angioplasty procedures?

The Asahi PTCA Guide Wire Asahi SION Series is engineered with a Composite Core SION TECC construction to enhance tip flexibility and durability, making it easier to navigate through complex coronary artery anatomy. This design also maintains torque response, ensuring stable advancement of the wire during balloon dilation procedures.

Is the Asahi PTCA Guide Wire Asahi SION Series intended for reuse, or is it meant to be used only once?

The device is explicitly labeled as single-use only. Reuse is not recommended, as it could compromise performance, sterility, or safety during interventional cardiology procedures.

How should the Asahi PTCA Guide Wire Asahi SION Series be stored to maintain its performance?

The manufacturer requires proper handling and storage per their instructions to preserve the device’s integrity. While no specific storage conditions (e.g., temperature, humidity) are detailed in the provided data, adherence to the included guidelines is essential to ensure the wire’s navigability and durability during use.

Are there any known restrictions on using this guide wire in patients who require MRI scans?

The available data does not mention any MRI safety restrictions for the Asahi PTCA Guide Wire Asahi SION Series. However, clinicians should always verify compatibility with the specific MRI system and patient conditions, as metal components in guide wires could theoretically pose risks in magnetic fields.

What regulatory pathway was followed for FDA clearance of this guide wire, and which committee reviewed it?

The Asahi PTCA Guide Wire Asahi SION Series received FDA 510(k) clearance (K191464) under the Traditional review pathway, with a substantially equivalent (SESE) determination. The Cardiovascular (CV) Advisory Committee reviewed the submission, and the device falls under the DQX product code for vascular intervention devices.

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: ASAHI SION® | Asahi Intecc Medical, PDF ASAHI PTCA Guide Wire, PDF ASAHI PTCA Guide Wire, ASAHI SION | Medical products for Coronary | ASAHI INTECC PRODUCTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (1)

  • FDA 510(k) K191464 24 fields · synced Sep 19, 2026