Apparatus, Autotransfusion
FDA product code CAC · 192 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.5830
- Review panel
- CV
- Implant
- No
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-12-22 – 2024-08-16
CAC
2024-08-16
CAC
2024-05-14
Aventus Clot Management System
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CAC
2024-04-29
XTRA Autotransfusion System (with XTRA Bowl sets)
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CAC
2023-07-14
FlowSaver Blood Return System (80-101)
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CAC
2023-02-17
FlowSaver Blood Return System
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CAC
2022-11-15
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
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CAC
2021-09-03
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
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CAC
2021-07-29
Hemafuse System
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CAC
2021-07-22
FlowSaver Blood Filter
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CAC
2021-02-11
CATSmart, Automated Blood Processing Autotransfusion System
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CAC
2020-06-01
ProCell Surgical Sponge-Blood Recovery Unit
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CAC
2019-09-27
CATSmart
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CAC
2018-12-10
CATSmart
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CAC
2018-08-22
autoLog IQ Autotransfusion System
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CAC
2017-01-03
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
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CAC
2016-09-16
CATSmart
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CAC
2016-05-24
Haemonetics Cell Saver Elite Autotransfusion System
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CAC
2013-02-12
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
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CAC
2012-12-10
PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
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CAC
2012-10-25
ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
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CAC
2012-05-22
CELL SAVER ELITE
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CAC
2011-09-06
XTRA
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CAC
2011-04-07
XVAC
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CAC
2010-12-03
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
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CAC
2010-11-23
PREASSEMBLED SURGICAL WASH SET
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CAC
2010-10-05
XTRA AUTOTRANSFUSION SYSTEM
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CAC
2010-03-22
AUTOLOG AUTOTRANSFUSION SYSTEM
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CAC
2008-10-24
PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
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CAC
2006-09-28
CYTORI CELUTION CELL CONCENTRATION DEVICE
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CAC
2005-11-21
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
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CAC
2005-01-04
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
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CAC
2004-12-08
EXPRESS AND OASIS CHEST DRAIN
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CAC
2004-10-14
HEMOVAC BLOOD REINFUSION SYSTEM
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CAC
2003-07-25
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
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CAC
2003-03-07
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
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CAC
2003-02-14
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
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CAC
2002-10-09
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
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CAC
2002-09-05
DIDECO ELECTA
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CAC
2002-08-15
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
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CAC
2002-03-26
ACCESS SEQUESTRATION SYSTEM
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CAC
2002-02-06
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
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CAC
2002-01-08
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
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CAC
2001-07-23
FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
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CAC
1999-11-18
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
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CAC
1999-10-18
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
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CAC
1999-09-09
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
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CAC
1999-04-02
SMARTCELL PROCESSING SYSTEM
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CAC
1999-03-30
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
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CAC
1999-02-01
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
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CAC
1998-12-18
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
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CAC
1998-12-16
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
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CAC
1998-11-30
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
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CAC
1998-08-20
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
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CAC
1998-04-27
AUTOTRANSFUSION APPARTUS (AUTOLOG)
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CAC
1998-03-31
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
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CAC
1998-02-20
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
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CAC
1998-02-20
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
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CAC
1997-12-16
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
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CAC
1997-11-05
ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
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CAC
1997-11-03
STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
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CAC
1997-11-03
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
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CAC
1997-06-13
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
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CAC
1997-04-22
PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
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CAC
1997-02-20
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
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CAC
1997-01-28
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP)
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CAC
1996-12-31
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
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CAC
1996-12-10
HAEMOCELL SYSTEM 350 OR S350
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CAC
1996-11-08
PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
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CAC
1996-07-31
C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
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CAC
1996-06-20
AUTOVAC BP SYSTE, 2000 SERIES
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CAC
1996-04-26
LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
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CAC
1996-03-04
BETATRANS I AND II
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CAC
1996-02-23
CARACELL
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CAC
1995-11-17
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
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CAC
1995-10-19
BOEHRINGER AUTOVAC(R) 7900 SERIES
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CAC
1995-07-20
AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
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CAC
1995-05-10
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
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CAC
1995-01-27
DIDECO VACUUM PUMP
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CAC
1995-01-19
DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM
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CAC
1994-11-15
DAVOL ATS
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CAC
1994-07-26
PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
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CAC
1994-07-06
AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
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CAC
1994-06-10
PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
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CAC
1994-04-15
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
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CAC
1994-01-05
CELL SAVER 5 SYSTEM
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CAC
1993-12-29
BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
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CAC
1993-10-08
DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
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CAC
1993-10-06
BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
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CAC
1993-07-29
IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
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CAC
1993-03-12
AUTOTRANSFUSION SUCTION SET
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CAC
1993-02-25
SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
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CAC
1993-02-25
SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
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CAC
1993-02-22
MAT MEMBRANE AUTOTRANSFUSION SYSTEM
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CAC
1993-02-05
AUTOVAC 7900 SERIES
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CAC
1993-01-28
HEMOVAC AUTOTRANSFUSION SYSTEM
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CAC
1992-12-03
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
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CAC
1992-11-23
AUTOLOGOUS BLOOD COLLECTION SET
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CAC
1992-09-25
SYSTEM 350
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CAC
1992-05-20
AUTOLOGOUS BLOOD PROCESSING SYSTEM
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CAC
1992-01-27
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
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