FDA.report

510(k) K221722

Device
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
Applicant
Haemonetics Corporation
510(k) number
K221722
Product code
CAC
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-15
Date received
2022-06-14
Regulation
868.5830
Classification name
Apparatus, Autotransfusion
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ergang Alexis
Address
125 Summer St. Boston MA US 02110 02110

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K180831CATSmartFresenius Kabi AG2018-12-10
K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems2018-08-22
K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation2017-01-03
K160735CATSmartFresenius Kabi AG2016-09-16