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ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
510(k) K171613
Identifiers
- 510(k) Number
- K171613 FDA 510(k)
- FDA Product Code
- MOF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip by Asahi Intecc Co., Ltd. — Class II — MDD, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171613 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (2)
- FDA 510(k) K171613 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026