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ASAHI PTCA Guide Wire Fielder FC 180cm J
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref AGP140001J510(k) K063819
Identity
- Trade Name
- ASAHI PTCA Guide Wire Fielder FC 180cm J EUDAMED
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMED
- Model / Reference
- AGP140001J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327077729 EUDAMED
- Basic UDI-DI
- B-04547327077729 EUDAMED
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
ASAHI PTCA Guide Wire Fielder FC 180cm J by Asahi Intecc Co., Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063819 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327077729 | Class III | Active |
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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 (2)
- EUDAMED ed8a650c-8495-4621-aef2-98e56c03f9d3 85 fields · synced Jun 18, 2026
- FDA 510(k) K063819 1 fields · synced May 18, 2026