510(k) K251576
K251576 is an FDA 510(k) premarket notification submitted by Total Flow Medical Limited for the device "Total Flow Medical Femoral Arterial (TFA) cannula". The FDA issued a decision of Substantially Equivalent on Jul 23, 2026.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2026
- Date Received
- May 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No