Clearance Summary
Capiflo 5001 received FDA 510(k) clearance under submission number K222158, sponsored by K&L Distributing, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-01-20.
- Submission: K222158
- Applicant / Sponsor: K&L Distributing, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2023-01-20
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.