ClearanceBrief
Panels › Anesthesiology › Product code CAC · Class 2

Apparatus, Autotransfusion

Regulation 868.5830

0510(k)s in 12 months (195 all time)
0recalls in 12 months (114 all time)
99recalls that name a 510(k)
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Top companies in CAC

Company510(k)sRecalls
Haemonetics Corp.1839
Atrium Medical Corp.1019
Stryker Instruments Div. of Stryker Corporation029
Cobe Cardiovascular, Inc.710
Boehringer Laboratories121
Deknatel, Inc.110
Shiley, Inc.110
Electromedics, Inc.70
Fresenius Kabi AG43
Solco Basle, Inc.70
Decided510(k)Device and applicantCode
Aug 16, 2024K241236XTRA Collection sets; XTRA Sequestration set X
Sorin Group Italia S.R.L., IT
CAC
May 14, 2024K240426Aventus Clot Management System
Inquis Medical
CAC
Apr 29, 2024K240584XTRA Autotransfusion System (with XTRA Bowl sets)
Sorin Group Italia S.R.L., IT
CAC
Jul 14, 2023K231782FlowSaver Blood Return System (80-101)
Inari Medical, Inc.
CAC
Feb 17, 2023K221483FlowSaver Blood Return System
Inari Medical, Inc.
CAC
Nov 15, 2022K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
Haemonetics Corporation
CAC
Sep 3, 2021K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry
Atrium Medical Corporation
CAC
Jul 29, 2021K210862Hemafuse System
Sisu Global Health
CAC
Jul 22, 2021K210176FlowSaver Blood Filter
Inari Medical
CAC
Feb 11, 2021K210089CATSmart, Automated Blood Processing Autotransfusion System
Fresenius Kabi AG, DE
CAC
Jun 1, 2020K193361ProCell Surgical Sponge-Blood Recovery Unit
Procell Surgical, Inc., CA
CAC
Sep 27, 2019K192368CATSmart
Fresenius Kabi AG, DE
CAC
Dec 10, 2018K180831CATSmart
Fresenius Kabi AG, DE
CAC
Aug 22, 2018K181954autoLog IQ Autotransfusion System
Medtronic Perfusion Systems
CAC
Jan 3, 2017K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
Haemonetics Corporation
CAC
Sep 16, 2016K160735CATSmart
Fresenius Kabi AG, DE
CAC
May 24, 2016K160197Haemonetics Cell Saver Elite Autotransfusion System
Haemonetics Corporation
CAC
Oct 23, 2014K140205PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
Teleflexmedical, Inc.
CAC
Oct 21, 2014K140197PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
Teleflexmedical, Inc.
CAC
Mar 21, 2014K131553XTRA
Sorin Group Deutschland GmbH
CAC
Feb 12, 2013K130043PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
Teleflexmedical, Inc.
CAC
Dec 10, 2012K120953PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
Tlelflex Medical, Inc.
CAC
Oct 25, 2012K122262ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
Haemonetics Corp.
CAC
May 22, 2012K120586CELL SAVER ELITE
Haemonetics Corp.
CAC
Sep 6, 2011K112245XTRA
Sorin Group Italia S.R.L.
CAC
Apr 7, 2011K110782XVAC
Sorin Group Italia S.R.L.
CAC
Dec 3, 2010K101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
Haemonetics Corp.
CAC
Nov 23, 2010K103202PREASSEMBLED SURGICAL WASH SET
Sorin Group Italia S.R.L.
CAC
Oct 5, 2010K101586XTRA AUTOTRANSFUSION SYSTEM
Sorin Group Italia S.R.L.
CAC
Mar 22, 2010K093535AUTOLOG AUTOTRANSFUSION SYSTEM
Medtronic, Inc.
CAC
Oct 24, 2008K082923PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
Life-Tech, Inc.
CAC
Sep 28, 2006K060482CYTORI CELUTION CELL CONCENTRATION DEVICE
Cytori Therapeutics, Inc.
CAC
Nov 21, 2005K053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
Haemonetics Corp.
CAC
Jan 4, 2005K043127HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
Haemonetics Corp.
CAC
Dec 8, 2004K043140EXPRESS AND OASIS CHEST DRAIN
Atrium Medical Corp.
CAC
Oct 14, 2004K041525HEMOVAC BLOOD REINFUSION SYSTEM
Zimmer, Inc.
CAC
Jul 25, 2003K031554S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
Genzyme Biosurgery
CAC
Mar 7, 2003K022167PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
Pall Corp.
CAC
Feb 14, 2003K024097SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
Summit Medical , Ltd., GB
CAC
Oct 9, 2002K022489SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
Summit Medical , Ltd., GB
CAC
Sep 5, 2002K020647DIDECO ELECTA
Dideco S.P.A.
CAC
Aug 15, 2002K022348ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
Interpore Cross Intl.
CAC
Mar 26, 2002K012406ACCESS SEQUESTRATION SYSTEM
Interpore Cross Intl.
CAC
Feb 6, 2002K014187AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
Boehringer Laboratories
CAC
Jan 8, 2002K014083HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
Haemonetics Corp.
CAC
Jul 23, 2001K012178FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
Fresenius Hemotechnology, Inc.
CAC
Nov 18, 1999K993581HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
Haemonetics Corp.
CAC
Oct 18, 1999K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
Transfusion Technologies Corp.
CAC
Sep 9, 1999K991986COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
Cobe Cardiovascular, Inc.
CAC
Apr 2, 1999K983022SMARTCELL PROCESSING SYSTEM
Harvest Technologies, LLC
CAC

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