FDA 510(k) Applications for Medical Device Product Code "DSP"
(System, Balloon, Intra-Aortic And Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K062582 | ABIOMED, INC. | SUPRACOR BALLOON CATHETER | 12/14/2006 |
| K070225 | ABIOMED, INC. | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | 12/13/2007 |
| K201112 | Arrow International Inc. | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | 05/27/2020 |
| K200634 | Arrow International Inc. | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | 04/09/2020 |
| K162820 | ARROW INTERNATIONAL, INC. | AC3 Series IABP System | 03/31/2017 |
| K190117 | Arrow International, Inc. | Fiberoptix IAB | 06/13/2019 |
| K190101 | Arrow International, Inc. | UltraFlex IAB | 06/28/2019 |
| K232343 | Arrow International, LLC | AC3Ö Series IABP | 08/30/2023 |
| K192238 | Arrow International, Teleflex | AC3 Series Intra-Aortic Balloon Pump (IABP) | 11/12/2019 |
| K963865 | ARROW INTL., INC. | 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S | 09/16/1997 |
| K963920 | ARROW INTL., INC. | 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, | 06/17/1997 |
| K960713 | ARROW INTL., INC. | 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) | 05/15/1996 |
| K993966 | ARROW INTL., INC. | 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER | 02/18/2000 |
| K963104 | ARROW INTL., INC. | 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM | 02/04/1997 |
| K965209 | ARROW INTL., INC. | ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) | 01/23/1998 |
| K002256 | ARROW INTL., INC. | ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP | 05/03/2001 |
| K021462 | ARROW INTL., INC. | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 | 06/06/2002 |
| K010330 | ARROW INTL., INC. | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U | 03/02/2001 |
| K961358 | ARROW INTL., INC. | ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER | 07/02/1996 |
| K000729 | ARROW INTL., INC. | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL | 05/19/2000 |
| K060309 | ARROW INTL., INC. | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | 04/06/2006 |
| K970689 | ARROW INTL., INC. | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U | 06/04/1998 |
| K040801 | ARROW INTL., INC. | INTRA-AORTIC BALLOON (IAB) | 05/06/2004 |
| K983866 | BELMONT INSTRUMENT CORP. | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP | 01/06/2000 |
| K982538 | BELMONT INSTRUMENT CORP. | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP | 10/02/1998 |
| K972113 | BOSTON SCIENTIFIC CORP. | 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL | 09/02/1997 |
| K974247 | BOSTON SCIENTIFIC CORP. | 40 CC GRANDE | 02/10/1998 |
| K971673 | BOSTON SCIENTIFIC CORP. | 40 CC SUMO | 08/05/1997 |
| K963187 | BOSTON SCIENTIFIC CORP. | MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C | 11/04/1996 |
| K954431 | BOSTON SCIENTIFIC CORP. | PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS | 01/11/1996 |
| K981660 | C.R. BARD, INC. | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters | 10/16/1998 |
| K973962 | C.R. BARD, INC. | BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS | 02/19/1998 |
| K980850 | C.R. BARD, INC. | BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS | 06/03/1998 |
| K962177 | C.R. BARD, INC. | BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT | 09/04/1996 |
| K112372 | CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP | 09/15/2011 |
| K112327 | CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES | 09/09/2011 |
| K163542 | Datascope Corp. | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | 01/31/2017 |
| K151254 | DATASCOPE CORP. | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | 07/02/2015 |
| K181122 | Datascope Corp. | CARDIOSAVE Intra-Aortic Balloon Pump | 05/31/2018 |
| K031636 | DATASCOPE CORP. | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX | 08/11/2003 |
| K172305 | Datascope Corp. | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | 10/12/2017 |
| K041281 | DATASCOPE CORP. | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES | 06/07/2004 |
| K980385 | DATASCOPE CORP. | DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES | 05/01/1998 |
| K031569 | DATASCOPE CORP. | DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX | 06/10/2003 |
| K063525 | DATASCOPE CORP. | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | 01/05/2007 |
| K964987 | DATASCOPE CORP. | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 | 03/17/1997 |
| K980780 | DATASCOPE CORP. | DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES | 05/29/1998 |
| K003598 | DATASCOPE CORP. | DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 | 12/21/2000 |
| K020257 | DATASCOPE CORP. | DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S | 04/24/2002 |
| K994157 | DATASCOPE CORP. | DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 | 03/13/2000 |
| K961509 | DATASCOPE CORP. | INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED | 11/15/1996 |
| K133074 | DATASCOPE CORP. | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | 12/12/2013 |
| K002949 | DATASCOPE CORP. | MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC | 10/20/2000 |
| K013326 | DATASCOPE CORP. | MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B | 11/02/2001 |
| K960166 | DATASCOPE CORP. | PERCOR STAT-DL 9.5 FR. 34 & 40CC | 04/24/1996 |
| K965236 | DATASCOPE CORP. | SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) | 07/01/1997 |
| K091449 | DATASCOPE CORP., CARDIAC ASSIST DIVISION | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 | 06/18/2009 |
| K120868 | DATASCOPE CORP., CARDIAC ASSIST DIVISION | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER | 04/20/2012 |
| K122628 | DATASCOPE CORP., CARDIAC ASSIST DIVISION | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES | 09/06/2012 |
| K082746 | INSIGHTRA MEDICAL, INC. | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | 01/12/2009 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
