Clearance Summary
ASAHI PTCA Guide Wire ASAHI Gaia Next received FDA 510(k) clearance under submission number K192599, 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 2020-01-02.
- Submission: K192599
- Applicant / Sponsor: Asahi Intecc Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2020-01-02
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.