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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K251576
Device Name Total Flow Medical Femoral Arterial (TFA) cannula
Applicant
Total Flow Medical Limited
081-2366 Main Mall
Vancouver,  CA V6T 1Z4
Applicant Contact Hillary Pierce
Correspondent
Total Flow Medical
1001 W Broadway
Vancouver,  CA V6H 4E4
Correspondent Contact Hillary Pierce
Classification Product Code
SFF
Date Received05/22/2025
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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