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Asahi Sion PTCA Guide Wire Model AHW14R001S & AHW14R301S

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K100578Ref AHW14R201S

by Asahi Intecc Co., Ltd.

Identity

Trade Name
SION EUDAMED
Device Name
PCI Guide Wire SION PCI Guide Wire SION blue PCI Guide Wire SION black PCI Guide Wire SION blue ES PCI Guide Wire SUOH 03 EUDAMED
Model / Reference
AHW14R201S EUDAMED

Identifiers

Primary DI / UDI-DI
04547327144247 EUDAMED
Basic UDI-DI
4547327BGW011N8 EUDAMED
510(k) Number
K100578 FDA 510(k)
FDA Product Code
DQX FDA 510(k)
EMDN Code
C04010201 CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC EUDAMED

Classification

Device Class
Class III EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Market of Registration
Austria EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

The Asahi Sion PTCA Guide Wire Model AHW14R001S & AHW14R301S 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 to facilitate revascularization procedures.

These guidewires are supplied sterile and intended for single-use in interventional cardiology settings. They are classified under Product Code DQX and have received FDA 510(k) clearance under Special Review via the Cardiovascular Advisory Committee, as well as MDR authorization. The models AHW14R001S and AHW14R301S are identified by their distinct reference codes and are intended for use in controlled clinical environments.

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, ASAHI SION | Medical products for Coronary | ASAHI INTECC PRODUCTS, Asahi Sion Ptca Guide Wire Model Ahw14r001s & Ahw14r301s (K100578 ..., PDF ASAHI PTCA Guide Wire

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.

Sources (2)

  • FDA 510(k) K100578 24 fields · synced Oct 7, 2026
  • EUDAMED e74e4ced-7147-4db3-b277-547cb031380c 61 fields · synced Jul 8, 2026