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FDA 510(k)

Hemafuse System

K-Number: K210862 · 2021-07-29

ApplicantSisu Global Health
Decision Date2021-07-29
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hemafuse System is a medical device manufactured by Sisu Global Health. It received FDA 510(k) clearance on 2021-07-29 under approval number K210862. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemafuse System?

Hemafuse System is a medical device that received FDA 510(k) clearance on 2021-07-29. It is manufactured by Sisu Global Health. The 510(k) number is K210862.

When was Hemafuse System approved by the FDA?

Hemafuse System received FDA 510(k) clearance on 2021-07-29, under approval number K210862.

What company makes Hemafuse System?

Hemafuse System is manufactured by Sisu Global Health.

What is the FDA product code for Hemafuse System?

The FDA product code for Hemafuse System is CAC.

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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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