Atlas FDA

DSP

162 FDA 510(k) clearances · Product code

126 daysmedian time to decision
357 days90th percentile
162clearances measured

FDA profile

Official device name
System, Balloon, Intra-Aortic And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3535
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 4,345 · 2022: 5,113 · 2023: 6,980 · 2024: 7,319 · 2025: 7,504 · 2026: 5,844
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AC3™ Range™ Intra-Aortic Balloon Pump (K250542)Arrow International, LLC2025-03-26
AC3™ Series IABP (K232343)Arrow International, LLC2023-08-30
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (K201112)Arrow International, Inc.2020-05-27
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (K200634)Arrow International, Inc.2020-04-09
AC3 Series Intra-Aortic Balloon Pump (IABP) (K192238)Arrow International, Teleflex2019-11-12
UltraFlex IAB (K190101)Arrow International, Inc.2019-06-28
Fiberoptix IAB (K190117)Arrow International, Inc.2019-06-13
CARDIOSAVE Intra-Aortic Balloon Pump (K181122)Datascope Corp.2018-05-31
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305)Datascope Corp.2017-10-12
AC3 Series IABP System (K162820)Arrow International, Inc.2017-03-31
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542)Datascope Corp.2017-01-31
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254)Datascope Corp.2015-07-02
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES (K133074)Datascope Corp.2013-12-12
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES (K122628)Datascope Corp., Cardiac Assist Division2012-09-06
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER (K120868)Datascope Corp., Cardiac Assist Division2012-04-20
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372)Cardiac Assist, Maquet Cardiovascular, LLC2011-09-15
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES (K112327)Cardiac Assist, Maquet Cardiovascular, LLC2011-09-09
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 (K091449)Datascope Corp., Cardiac Assist Division2009-06-18
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (K082746)Insightra Medical, Inc.2009-01-12
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE (K070225)Abiomed, Inc.2007-12-13
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM (K063525)Datascope Corp.2007-01-05
SUPRACOR BALLOON CATHETER (K062582)Abiomed, Inc.2006-12-14
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES (K060309)Arrow Intl., Inc.2006-04-06
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES (K041281)Datascope Corp.2004-06-07
INTRA-AORTIC BALLOON (IAB) (K040801)Arrow Intl., Inc.2004-05-06
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX (K031636)Datascope Corp.2003-08-11
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX (K031569)Datascope Corp.2003-06-10
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 (K021462)Arrow Intl., Inc.2002-06-06
DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S (K020257)Datascope Corp.2002-04-24
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B (K013326)Datascope Corp.2001-11-02
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP (K002256)Arrow Intl., Inc.2001-05-03
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U (K010330)Arrow Intl., Inc.2001-03-02
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 (K003598)Datascope Corp.2000-12-21
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC (K002949)Datascope Corp.2000-10-20
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL (K000729)Arrow Intl., Inc.2000-05-19
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 (K994157)Datascope Corp.2000-03-13
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER (K993966)Arrow Intl., Inc.2000-02-18
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP (K983866)Belmont Instrument Corp.2000-01-06
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters (K981660)C.R. Bard, Inc.1998-10-16
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP (K982538)Belmont Instrument Corp.1998-10-02
IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U (K970689)Arrow Intl., Inc.1998-06-04
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS (K980850)C.R. Bard, Inc.1998-06-03
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES (K980780)Datascope Corp.1998-05-29
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES (K980385)Datascope Corp.1998-05-01
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS (K973962)C.R. Bard, Inc.1998-02-19
40 CC GRANDE (K974247)Boston Scientific Corp1998-02-10
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) (K965209)Arrow Intl., Inc.1998-01-23
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S (K963865)Arrow Intl., Inc.1997-09-16
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL (K972113)Boston Scientific Corp1997-09-02
40 CC SUMO (K971673)Boston Scientific Corp1997-08-05
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) (K965236)Datascope Corp.1997-07-01
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, (K963920)Arrow Intl., Inc.1997-06-17
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 (K964987)Datascope Corp.1997-03-17
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM (K963104)Arrow Intl., Inc.1997-02-04
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED (K961509)Datascope Corp.1996-11-15
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C (K963187)Boston Scientific Corp1996-11-04
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT (K962177)C.R. Bard, Inc.1996-09-04
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER (K961358)Arrow Intl., Inc.1996-07-02
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) (K960713)Arrow Intl., Inc.1996-05-15
PERCOR STAT-DL 9.5 FR. 34 & 40CC (K960166)Datascope Corp.1996-04-24
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS (K954431)Boston Scientific Corp1996-01-11
TRANSPORT CART (K952576)Belmont Instrument Corp.1995-12-26
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 (K952221)Boston Scientific Corp1995-08-11
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) (K950687)Belmont Instrument Corp.1995-05-24
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON (K945230)Arrow Intl., Inc.1995-05-09
BSC/CA MODEL 940 IAB (K940298)Boston Scientific Corp1995-04-06
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER (K943919)Boston Scientific Corp1995-03-23
DATASCOPE 95 AND 97 IAB PUMP CONSOLE (K942454)Datascope Corp.1995-02-24
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING (K935184)St. Jude Medical, Inc.1995-02-10
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD (K944460)Datascope Corp.1994-12-09
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER (K936232)Boston Scientific Corp1994-10-14
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION (K940231)Datascope Corp.1994-09-13
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION (K940178)Datascope Corp.1994-08-09
MODIFICATIONS TO INTRA-AORTIC BALLOONS (K932268)Kontron Instruments, Inc.1993-12-15
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (K925248)Kontron Instruments, Inc.1993-09-27
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER (K926000)Boston Scientific Corp1993-08-30
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL (K914802)Datascope Corp.1993-08-25
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON (K911000)Datascope Corp.1993-08-25
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON (K920427)Datascope Corp.1993-08-03
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS (K905663)Datascope Corp.1993-08-02
SYSTEM 97 (K922235)Datascope Corp.1993-04-27
BARD(R) INTRA AORTIC BALLOON (K924382)C.R. Bard, Inc.1993-04-07
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE (K921638)Datascope Corp.1993-02-10
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP (K915580)Belmont Instrument Corp.1992-10-30
DATASCOPE SYSTEM 95 (K912629)Datascope Corp.1992-03-11
SYSTEM 90 AND SYSTEM 90T (K913847)Datascope Corp.1992-03-11
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON (K910997)Datascope Corp.1991-11-05
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (K905313)Kontron Instruments, Inc.1991-06-19
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT (K905056)Datascope Corp.1991-06-11
COMPACT MONITOR SMK 210,211,230,231,240 (K903917)Ppg Hellige B.V.1991-01-18
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (K903344)Kontron Instruments, Inc.1991-01-15
DATASCOPE PERCOR STAT DL 10.5 FR 50CC (K903930)Datascope Corp.1990-11-16
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS (K904414)Datascope Corp.1990-10-22
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON (K903769)Datascope Corp.1990-10-19
DATASCOPE PERCOR STAT DL 10.5 FR 40CC (K903867)Datascope Corp.1990-10-19
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL (K904018)Datascope Corp.1990-10-19
DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL (K903892)Datascope Corp.1990-10-19
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL (K903893)Datascope Corp.1990-10-19
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL (K903736)Datascope Corp.1990-10-09
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG (K902057)Datascope Corp.1990-09-25
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