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ASAHI PTCA Guide Wire, 0.014", ASAHI SUOH 03 190cm Pre-shape
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref AHW14R013P510(k) K162842
Identity
- Trade Name
- ASAHI PTCA Guide Wire, 0.014", ASAHI SUOH 03 190cm Pre-shape EUDAMED
- Device Name
- ASAHI PTCA Guide Wire ASAHI SION and SUOH 03 EUDAMED
- Model / Reference
- AHW14R013P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327116794 EUDAMED
- Basic UDI-DI
- B-04547327116794 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, 0.014", ASAHI SUOH 03 190cm Pre-shape by Asahi Intecc Co., Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K083904 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K162842 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327116794 | 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 8fb30f9d-479b-4f5b-8e96-967df152ceca 85 fields · synced Jun 19, 2026
- FDA 510(k) K083904 1 fields · synced May 18, 2026