System, Balloon, Intra-Aortic And Control
FDA product code DSP · 161 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.3535
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-10-06 – 2025-03-26
DSP
2025-03-26
DSP
2023-08-30
AC3™ Series IABP
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DSP
2020-05-27
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
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DSP
2020-04-09
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
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DSP
2019-11-12
AC3 Series Intra-Aortic Balloon Pump (IABP)
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DSP
2019-06-28
UltraFlex IAB
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DSP
2019-06-13
Fiberoptix IAB
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DSP
2018-05-31
CARDIOSAVE Intra-Aortic Balloon Pump
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DSP
2017-10-12
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
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DSP
2017-03-31
AC3 Series IABP System
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DSP
2017-01-31
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
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DSP
2013-12-12
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
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DSP
2012-09-06
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
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DSP
2012-04-20
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
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DSP
2011-09-15
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
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DSP
2011-09-09
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
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DSP
2009-06-18
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
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DSP
2009-01-12
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
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DSP
2007-12-13
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
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DSP
2007-01-05
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
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DSP
2006-12-14
SUPRACOR BALLOON CATHETER
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DSP
2006-04-06
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
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DSP
2004-06-07
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
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DSP
2004-05-06
INTRA-AORTIC BALLOON (IAB)
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DSP
2003-08-11
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
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DSP
2003-06-10
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
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DSP
2002-06-06
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
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DSP
2002-04-24
DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
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DSP
2001-11-02
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
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DSP
2001-05-03
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
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DSP
2001-03-02
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
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DSP
2000-12-21
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
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DSP
2000-10-20
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
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DSP
2000-05-19
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
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DSP
2000-03-13
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
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DSP
2000-02-18
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
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DSP
2000-01-06
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
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DSP
1998-10-16
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
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DSP
1998-10-02
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
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DSP
1998-06-04
IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U
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DSP
1998-06-03
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
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DSP
1998-05-29
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
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DSP
1998-05-01
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
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DSP
1998-02-19
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
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DSP
1998-02-10
40 CC GRANDE
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DSP
1998-01-23
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
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DSP
1997-09-16
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
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DSP
1997-09-02
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
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DSP
1997-08-05
40 CC SUMO
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DSP
1997-07-01
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
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DSP
1997-06-17
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
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DSP
1997-03-17
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
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DSP
1997-02-04
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
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DSP
1996-11-15
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
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DSP
1996-11-04
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
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DSP
1996-09-04
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
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DSP
1996-07-02
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
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DSP
1996-05-15
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
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DSP
1996-04-24
PERCOR STAT-DL 9.5 FR. 34 & 40CC
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DSP
1996-01-11
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
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DSP
1995-12-26
TRANSPORT CART
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DSP
1995-08-11
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
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DSP
1995-05-24
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
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DSP
1995-05-09
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
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DSP
1995-04-06
BSC/CA MODEL 940 IAB
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DSP
1995-03-23
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
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DSP
1995-02-24
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
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DSP
1995-02-10
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
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DSP
1994-12-09
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
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DSP
1994-10-14
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
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DSP
1994-09-13
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
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DSP
1994-08-09
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
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DSP
1993-12-15
MODIFICATIONS TO INTRA-AORTIC BALLOONS
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DSP
1993-09-27
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
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DSP
1993-08-30
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
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DSP
1993-08-25
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
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DSP
1993-08-25
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
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DSP
1993-08-03
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
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DSP
1993-08-02
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
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DSP
1993-04-27
SYSTEM 97
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DSP
1993-04-07
BARD(R) INTRA AORTIC BALLOON
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DSP
1993-02-10
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
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DSP
1992-10-30
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP
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DSP
1992-03-11
SYSTEM 90 AND SYSTEM 90T
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DSP
1992-03-11
DATASCOPE SYSTEM 95
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DSP
1991-11-05
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
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DSP
1991-06-19
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
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DSP
1991-06-11
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
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DSP
1991-01-18
COMPACT MONITOR SMK 210,211,230,231,240
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DSP
1991-01-15
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
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DSP
1990-11-16
DATASCOPE PERCOR STAT DL 10.5 FR 50CC
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DSP
1990-10-22
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
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DSP
1990-10-19
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
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DSP
1990-10-19
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
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DSP
1990-10-19
DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
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DSP
1990-10-19
DATASCOPE PERCOR STAT DL 10.5 FR 40CC
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DSP
1990-10-19
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
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DSP
1990-10-09
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
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DSP
1990-09-25
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
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DSP
1990-09-14
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
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