ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR— 510(k) K141751
Substantially EquivalentAsahi Intecc Co., Ltd.
FDA 510(k) clearance K141751 for ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR, Substantially Equivalent on 2015-01-30. Applicant: Asahi Intecc Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Asahi Intecc Co., Ltd.
- Product code
- Code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code MOF
view allMore clearances from Asahi Intecc Co., Ltd.
view allAdverse 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.