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FDA 510(k)

Total Flow Medical Femoral Arterial (TFA) cannula

K-Number: K251576 · 2026-07-23

ApplicantTotal Flow Medical Limited
Decision Date2026-07-23
Product CodeSFF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Total Flow Medical Femoral Arterial (TFA) cannula is the device name listed in this FDA 510(k) record. The listed applicant is Total Flow Medical Limited. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K251576. The device is classified under product code SFF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Total Flow Medical Femoral Arterial (TFA) cannula?

Total Flow Medical Femoral Arterial (TFA) cannula is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Total Flow Medical Limited. The 510(k) number is K251576.

When did Total Flow Medical Femoral Arterial (TFA) cannula receive FDA 510(k) clearance?

Total Flow Medical Femoral Arterial (TFA) cannula received FDA 510(k) clearance on 2026-07-23, under 510(k) number K251576.

Who is the listed applicant for Total Flow Medical Femoral Arterial (TFA) cannula?

The FDA 510(k) record lists Total Flow Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Total Flow Medical Femoral Arterial (TFA) cannula?

The FDA product code for Total Flow Medical Femoral Arterial (TFA) cannula is SFF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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