ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010— 510(k) K183070
Substantially EquivalentAsahi Intecc Co., Ltd.
FDA 510(k) clearance K183070 for ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010, Substantially Equivalent on 2019-01-29. Applicant: Asahi Intecc Co., Ltd..
Clearance details
- Applicant
- Asahi Intecc Co., Ltd.
- Product code
- Code MOF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seto, JP
Adverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.