Total Flow Medical Femoral Arterial (TFA) cannula
FDA 510(k) clearance K251576 · decided 2026-07-23
Clearance details
- K-number
- K251576
- Device name
- Total Flow Medical Femoral Arterial (TFA) cannula
- Applicant
- Total Flow Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-05-22
- Decision date
- 2026-07-23
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- SFF
- Advisory committee
- Cardiovascular
- Location
- Vancouver, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.