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FDA 510(k)

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

K-Number: K221722 · 2022-11-15

ApplicantHaemonetics Corporation
Decision Date2022-11-15
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is a medical device manufactured by Haemonetics Corporation. It received FDA 510(k) clearance on 2022-11-15 under approval number K221722. 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 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by Haemonetics Corporation. The 510(k) number is K221722.

When was Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) approved by the FDA?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) received FDA 510(k) clearance on 2022-11-15, under approval number K221722.

What company makes Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is manufactured by Haemonetics Corporation.

What is the FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

The FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is CAC.

Related Clinical Trials

NCT06872684 Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD) RECRUITING

Other Devices by Haemonetics Corporation

K160197Haemonetics Cell Saver Elite Autotransfusion System K160502TEG 6s Hemostasis System K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge K232018Citrated: K, KH, RTH, FFH K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

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Related Devices (Code: CAC)

K160735CATSmartFresenius Kabi AG K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation K180831CATSmartFresenius Kabi AG K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems K192368CATSmartFresenius Kabi AG

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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