Clearance Summary
Total Flow Medical Femoral Arterial (TFA) cannula received FDA 510(k) clearance under submission number K251576, sponsored by Total Flow Medical Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-07-23.
- Submission: K251576
- Applicant / Sponsor: Total Flow Medical Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class:
- Decision date: 2026-07-23
Classification & Regulation
This clearance is catalogued under FDA product code SFF , within the Cardiovascular review panel as a device.