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FDA 510(k)

Haemonetics Cell Saver Elite Autotransfusion System

K-Number: K160197 · 2016-05-24

ApplicantHaemonetics Corporation
Decision Date2016-05-24
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Haemonetics Cell Saver Elite Autotransfusion System is a medical device manufactured by Haemonetics Corporation. It received FDA 510(k) clearance on 2016-05-24 under approval number K160197. 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 Autotransfusion System?

Haemonetics Cell Saver Elite Autotransfusion System is a medical device that received FDA 510(k) clearance on 2016-05-24. It is manufactured by Haemonetics Corporation. The 510(k) number is K160197.

When was Haemonetics Cell Saver Elite Autotransfusion System approved by the FDA?

Haemonetics Cell Saver Elite Autotransfusion System received FDA 510(k) clearance on 2016-05-24, under approval number K160197.

What company makes Haemonetics Cell Saver Elite Autotransfusion System?

Haemonetics Cell Saver Elite Autotransfusion System is manufactured by Haemonetics Corporation.

What is the FDA product code for Haemonetics Cell Saver Elite Autotransfusion System?

The FDA product code for Haemonetics Cell Saver Elite Autotransfusion System 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

K160502TEG 6s Hemostasis System K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) 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 K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation K180831CATSmartFresenius Kabi AG K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems K192368CATSmartFresenius Kabi AG K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc.

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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