Clearance Summary
SMARTFLOW received FDA 510(k) clearance under submission number K012947, sponsored by Florence Medical , 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 2001-10-02.
- Submission: K012947
- Applicant / Sponsor: Florence Medical , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2001-10-02
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.