Clearance Summary
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR received FDA 510(k) clearance under submission number K141751, sponsored by Asahi Intecc Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-01-30.
- Submission: K141751
- Applicant / Sponsor: Asahi Intecc Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2015-01-30
Classification & Regulation
This clearance is catalogued under FDA product code MOF and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.