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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 the device name listed in this FDA 510(k) record. The listed applicant is Sisu Global Health. It received FDA 510(k) clearance on 2021-07-29 under 510(k) 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. The listed applicant is Sisu Global Health. The 510(k) number is K210862.

When did Hemafuse System receive FDA 510(k) clearance?

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

Who is the listed applicant for Hemafuse System?

The FDA 510(k) record lists Sisu Global Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemafuse System?

The FDA product code for Hemafuse System is CAC.

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

Official Source

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

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