Product code CAC

Current FDA Classification

Device name
Apparatus, Autotransfusion
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.5830
Review panel
CV
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.2024-08-16
K240426Aventus Clot Management SystemInquis Medical2024-05-14
K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.2024-04-29
K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.2023-07-14
K221483FlowSaver Blood Return SystemInari Medical, Inc.2023-02-17
K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation2022-11-15
K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainAtrium Medical Corporation2021-09-03
K210862Hemafuse SystemSisu Global Health2021-07-29
K210176FlowSaver Blood FilterInari Medical2021-07-22
K210089CATSmart, Automated Blood Processing Autotransfusion SystemFresenius Kabi AG2021-02-11
K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc.2020-06-01
K192368CATSmartFresenius Kabi AG2019-09-27
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
K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation2016-05-24
K140205PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMTeleflexmedical, Inc.2014-10-23
K140197PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMTeleflexmedical, Inc.2014-10-21
K131553XTRASorin Group Deutschland GmbH2014-03-21
K130043PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMTeleflexmedical, Inc.2013-02-12
K120953PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEMTlelflex Medical, Inc.2012-12-10
K122262ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEMHaemonetics Corp.2012-10-25
K120586CELL SAVER ELITEHaemonetics Corp.2012-05-22
K112245XTRASorin Group Italia S.R.L.2011-09-06
K110782XVACSorin Group Italia S.R.L.2011-04-07
K101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMHaemonetics Corp.2010-12-03
K103202PREASSEMBLED SURGICAL WASH SETSorin Group Italia S.R.L.2010-11-23
K101586XTRA AUTOTRANSFUSION SYSTEMSorin Group Italia S.R.L.2010-10-05
K093535AUTOLOG AUTOTRANSFUSION SYSTEMMedtronic, Inc.2010-03-22

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