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ASAHI PTCA Guide Wire Fielder XT-A
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref APW14R009S
Identity
- Trade Name
- ASAHI PTCA Guide Wire Fielder XT-A EUDAMED
- Device Name
- ASAHI PTCA Guide Wire Fielder XT-A ASAHI PTCA Guide Wire Fielder XT-R EUDAMED
- Model / Reference
- APW14R009S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327088145 EUDAMED
- Basic UDI-DI
- B-04547327088145 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 XT-A 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 | K153106 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327088145 | 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 2d9c8592-dc05-42f1-8e07-a7b585af0538 61 fields · synced Jul 17, 2026
- FDA 510(k) K153106 1 fields · synced Jun 9, 2026