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ASAHI Peripheral Guide Wire Astato XS 40
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref PAGHW143094510(k) K153443Ref PAGHW143094
Identity
- Trade Name
- ASAHI Peripheral Guide Wire Astato XS 40 EUDAMEDAstato XS 40 EUDAMED
- Device Name
- ASAHI Peripheral Guide Wire EUDAMEDPeripheral Guide Wire Astato 30, Astato XS 20, Astato XS 40, Halberd, ASAHI Gaia PV, Gladius, Gladius MG14 PV, Gladius MG14 PV ES, Gladius MG18 PV ES EUDAMED
- Model / Reference
- PAGHW143094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327108751 EUDAMED
- Basic UDI-DI
- B-04547327108751 EUDAMED4547327DGW010NY EUDAMED
- EMDN Code
- C04020201 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa 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
EUDAMEDEUDAMED
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 Peripheral Guide Wire Astato XS 40 by Asahi Intecc Co., Ltd. — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153443 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04547327108751 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04547327108751 | Class IIa | 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 (3)
- EUDAMED ed4829b2-ba5b-480f-9d49-32c82ca117f2 85 fields · synced Jul 15, 2026
- EUDAMED c37af985-f8d9-4321-a131-745ce0f0fc41 61 fields · synced May 18, 2026
- FDA 510(k) K153443 1 fields · synced May 18, 2026