Total Flow Medical Femoral Arterial (TFA) cannula— 510(k) K251576
Substantially EquivalentTotal Flow Medical Limited
FDA 510(k) clearance K251576 for Total Flow Medical Femoral Arterial (TFA) cannula, Substantially Equivalent on 2026-07-23. Applicant: Total Flow Medical Limited.
Summary
The Total Flow Medical Femoral Arterial (TFA) cannula is filed under product code SFF. This record gives no name, device class, or regulation number for SFF, and no cannula sizes.
Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Total Flow Medical filed from Vancouver, Canada. Review took 427 calendar days (May 22, 2025 to July 23, 2026).
Clearance details
- Applicant
- Total Flow Medical Limited
- Product code
- Product code SFF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vancouver, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.