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ASAHI PTCA GUIDE WIRE ASAHI FIELDER 300cm

EUDAMEDFDA UDIFDA 510(k)

Class III (EU MDR)

Ref AGP140300

by Asahi Intecc Co., Ltd.

Identity

Trade Name
ASAHI PTCA GUIDE WIRE ASAHI FIELDER 300cm EUDAMED
FIELDER FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMED
Model / Reference
AGP140300 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
04547327056694 EUDAMEDFDA UDI
Basic UDI-DI
B-04547327056694 EUDAMED
FDA Product Code
DQX FDA UDI
EMDN Code
C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.014 Inch FDA UDI
Length — 300 Centimeter FDA UDI

ASAHI PTCA GUIDE WIRE ASAHI FIELDER 300cm by Asahi Intecc Co., Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Asahi Intecc Co., Ltd.
EUDAMED SRN
JP-MF-000010199
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 18fe247b-6860-4512-9796-e63547b94088 61 fields · synced Jun 19, 2026
  • FDA UDI 28037d98-53e6-41fc-a6e7-d84446b78006 33 fields · synced May 30, 2026
  • FDA 510(k) K052022 1 fields · synced May 18, 2026