Clearance Summary
FloPump 57mL Centrifugal Pump received FDA 510(k) clearance under submission number K193663, sponsored by International Biophysics Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-03-10.
- Submission: K193663
- Applicant / Sponsor: International Biophysics Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4360
- Decision date: 2021-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KFM and 21 CFR 870.4360, within the Cardiovascular review panel as a Class II device.