Clearance Summary
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip received FDA 510(k) clearance under submission number K171613, sponsored by Asahi Intecc Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-07-01.
- Submission: K171613
- Applicant / Sponsor: Asahi Intecc Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2017-07-01
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.