← Back to catalogue
ASAHI Peripheral Vascular Guide Wire ASAHI CHIKAI V 180cm
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref WCKV180-14
Identity
- Trade Name
- ASAHI Peripheral Vascular Guide Wire ASAHI CHIKAI V 180cm EUDAMED
- Device Name
- ASAHI Peripheral Vascular Guide Wire ASAHI CHIKAI V EUDAMED
- Model / Reference
- WCKV180-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327086523 EUDAMED
- Basic UDI-DI
- B-04547327086523 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
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 Peripheral Vascular Guide Wire ASAHI CHIKAI V 180cm by Asahi Intecc Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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 | K113716 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04547327086523 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
- EUDAMED SRN
- JP-MF-000010199
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 59748ae2-9374-4c4c-8521-a5c104f9c142 61 fields · synced Jul 21, 2026
- FDA 510(k) K113716 1 fields · synced May 18, 2026