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ASAHI Peripheral Guide Wire ASAHI Gladius
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref PPW14R100S510(k) K150445
Identity
- Trade Name
- ASAHI Peripheral Guide Wire ASAHI Gladius EUDAMED
- Device Name
- ASAHI Peripheral Guide Wire EUDAMED
- Model / Reference
- PPW14R100S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327106320 EUDAMED
- Basic UDI-DI
- B-04547327106320 EUDAMED
- 510(k) Number
- K150445 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
- EMDN Code
- C04020201 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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 Guide Wire ASAHI Gladius by Asahi Intecc Co., Ltd. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04547327106320 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K150445 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04547327106320 | 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 (2)
- EUDAMED a613e674-c981-44a1-8853-e886c75b9b53 61 fields · synced Jul 27, 2026
- FDA 510(k) K150445 24 fields · synced May 18, 2026