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ASAHI PTCA Guide Wire ASAHI SION blue 190cm Pre-shape
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref AHW14R104P
Identity
- Trade Name
- ASAHI PTCA Guide Wire ASAHI SION blue 190cm Pre-shape EUDAMEDASAHI SION blue FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- ASAHI PTCA Guide Wire ASAHI SION and SUOH 03 EUDAMED
- Model / Reference
- AHW14R104P EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547327132992 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04547327132992 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 EUDAMEDClass 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 UDILength — 190 Centimeter FDA UDI
ASAHI PTCA Guide Wire ASAHI SION blue 190cm Pre-shape 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122468 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327132992 | 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 (3)
- EUDAMED c4275b64-d691-4daa-8cea-aeb93403eca0 61 fields · synced Jun 19, 2026
- FDA UDI 762b708a-ab31-4a6f-a492-f1569c2b7e40 33 fields · synced May 30, 2026
- FDA 510(k) K122468 1 fields · synced May 18, 2026