FDA 510(k) Applications for Medical Device Product Code "CAC"
(Apparatus, Autotransfusion)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K043140 | ATRIUM MEDICAL CORP. | EXPRESS AND OASIS CHEST DRAIN | 12/08/2004 |
| K201305 | Atrium Medical Corporation | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain | 09/03/2021 |
| K955010 | BOEHRINGER LABORATORIES | AUTOVAC BP SYSTE, 2000 SERIES | 06/20/1996 |
| K014187 | BOEHRINGER LABORATORIES | AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM | 02/06/2002 |
| K962689 | COBE CARDIOVASCULAR, INC. | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) | 01/28/1997 |
| K991986 | COBE CARDIOVASCULAR, INC. | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION | 09/09/1999 |
| K974897 | COBE CARDIOVASCULAR, INC. | COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET | 03/31/1998 |
| K973627 | COBE CARDIOVASCULAR, INC. | STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM | 11/03/1997 |
| K060482 | CYTORI THERAPEUTICS, INC. | CYTORI CELUTION CELL CONCENTRATION DEVICE | 09/28/2006 |
| K970857 | DAVIS & GECK, INC. | ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO | 11/05/1997 |
| K964070 | DEKNATEL, INC. | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG | 12/31/1996 |
| K963850 | DEKNATEL, INC. | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | 04/22/1997 |
| K963098 | DEKNATEL, INC. | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) | 11/08/1996 |
| K982650 | DIDECO S.P.A. | AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) | 12/16/1998 |
| K020647 | DIDECO S.P.A. | DIDECO ELECTA | 09/05/2002 |
| K951592 | DUXBURY SCIENTIFIC INC. | BETATRANS I AND II | 03/04/1996 |
| K982241 | DUXBURY SCIENTIFIC INC. | BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX | 11/30/1998 |
| K971274 | FRESENIUS AG | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET | 06/13/1997 |
| K960006 | FRESENIUS AG | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM | 07/31/1996 |
| K984233 | FRESENIUS HEMOTECHNOLOGY, INC. | C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE | 02/01/1999 |
| K012178 | FRESENIUS HEMOTECHNOLOGY, INC. | FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW | 07/23/2001 |
| K160735 | FRESENIUS KABI AG | CATSmart | 09/16/2016 |
| K180831 | Fresenius Kabi AG | CATSmart | 12/10/2018 |
| K192368 | Fresenius Kabi AG | CATSmart | 09/27/2019 |
| K210089 | Fresenius Kabi AG | CATSmart, Automated Blood Processing Autotransfusion System | 02/11/2021 |
| K973378 | FRESENIUS USA, INC. | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 | 11/03/1997 |
| K031554 | GENZYME BIOSURGERY | S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | 07/25/2003 |
| K982712 | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 | 12/18/1998 |
| K960734 | HAEMOCELL PLC | HAEMOCELL SYSTEM 350 OR S350 | 12/10/1996 |
| K120586 | HAEMONETICS CORP. | CELL SAVER ELITE | 05/22/2012 |
| K043127 | HAEMONETICS CORP. | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM | 01/04/2005 |
| K053000 | HAEMONETICS CORP. | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) | 11/21/2005 |
| K014083 | HAEMONETICS CORP. | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM | 01/08/2002 |
| K101907 | HAEMONETICS CORP. | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | 12/03/2010 |
| K993581 | HAEMONETICS CORP. | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER | 11/18/1999 |
| K122262 | HAEMONETICS CORP. | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | 10/25/2012 |
| K160197 | Haemonetics Corporation | Haemonetics Cell Saver Elite Autotransfusion System | 05/24/2016 |
| K162423 | HAEMONETICS CORPORATION | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | 01/03/2017 |
| K221722 | Haemonetics Corporation | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | 11/15/2022 |
| K983022 | HARVEST TECHNOLOGIES, LLC. | SMARTCELL PROCESSING SYSTEM | 04/02/1999 |
| K210176 | Inari Medical | FlowSaver Blood Filter | 07/22/2021 |
| K221483 | Inari Medical, Inc. | FlowSaver Blood Return System | 02/17/2023 |
| K231782 | Inari Medical, Inc. | FlowSaver Blood Return System (80-101) | 07/14/2023 |
| K022348 | INTERPORE CROSS INTL. | ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 | 08/15/2002 |
| K012406 | INTERPORE CROSS INTL. | ACCESS SEQUESTRATION SYSTEM | 03/26/2002 |
| K942844 | LEVEL 1 TECHNOLOGIES, INC. | LEVEL 1 BLOOD STREAM RECOVERY SYSTEM | 04/26/1996 |
| K082923 | LIFE-TECH, INC. | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C | 10/24/2008 |
| K972894 | MEDTRONIC BLOOD MANAGEMENT | AUTOTRANSFUSION APPARTUS (AUTOLOG) | 04/27/1998 |
| K982755 | MEDTRONIC BLOOD MANAGEMENT | MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) | 08/20/1998 |
| K093535 | MEDTRONIC INC. | AUTOLOG AUTOTRANSFUSION SYSTEM | 03/22/2010 |
| K181954 | MEDTRONIC PERFUSION SYSTEMS | autoLog IQ Autotransfusion System | 08/22/2018 |
| K953118 | MEDTRONIC VASCULAR | CARACELL | 02/23/1996 |
| K022167 | PALL CORP. | PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM | 03/07/2003 |
| K193361 | ProCell Surgical, Inc. | ProCell Surgical Sponge-Blood Recovery Unit | 06/01/2020 |
| K210862 | Sisu Global Health | Hemafuse System | 07/29/2021 |
| K963758 | SORIN BIOMEDICAL, INC. | CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE | 02/20/1998 |
| K963759 | SORIN BIOMEDICAL, INC. | DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS | 02/20/1998 |
| K131553 | SORIN GROUP DEUTSCHLAND GMBH | XTRA | 03/21/2014 |
| K112245 | SORIN GROUP ITALIA S.R.L | XTRA | 09/06/2011 |
| K103202 | SORIN GROUP ITALIA S.R.L. | PREASSEMBLED SURGICAL WASH SET | 11/23/2010 |
| K101586 | SORIN GROUP ITALIA S.R.L. | XTRA AUTOTRANSFUSION SYSTEM | 10/05/2010 |
| K110782 | SORIN GROUP ITALIA S.R.L. | XVAC | 04/07/2011 |
| K970714 | STRYKER INSTRUMENTS | STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) | 12/16/1997 |
| K024097 | SUMMIT MEDICAL LTD. | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 | 02/14/2003 |
| K022489 | SUMMIT MEDICAL LTD. | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 | 10/09/2002 |
| K140197 | Teleflex Medical, Inc. | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | 10/21/2014 |
| K140205 | Teleflex Medical, Inc. | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | 10/23/2014 |
| K130043 | Teleflex Medical, Inc. | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | 02/12/2013 |
| K120953 | TLELFLEX MEDICAL, INC. | PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM | 12/10/2012 |
| K962475 | TRANSFUSION TECHNOLOGIES CORP. | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM | 02/20/1997 |
| K982660 | TRANSFUSION TECHNOLOGIES CORP. | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM | 03/30/1999 |
| K992723 | TRANSFUSION TECHNOLOGIES CORP. | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM | 10/18/1999 |
| K041525 | ZIMMER, INC. | HEMOVAC BLOOD REINFUSION SYSTEM | 10/14/2004 |
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