FDA Product Code
FDA Product Code DSP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3535
510(k) Clearances — 162 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon Pump | Arrow International, LLC | 2025-03-26 | Special | PDF ↗ |
| K232343 | AC3 Series IABP | Arrow International, LLC | 2023-08-30 | Special | PDF ↗ |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | Arrow International, Inc. | 2020-05-27 | Special | PDF ↗ |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | Arrow International, Inc. | 2020-04-09 | Special | PDF ↗ |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex | 2019-11-12 | Special | PDF ↗ |
| K190101 | UltraFlex IAB | Arrow International, Inc. | 2019-06-28 | Traditional | PDF ↗ |
| K190117 | Fiberoptix IAB | Arrow International, Inc. | 2019-06-13 | Traditional | PDF ↗ |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | 2018-05-31 | Special | PDF ↗ |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | Datascope Corp. | 2017-10-12 | Special | PDF ↗ |
| K162820 | AC3 Series IABP System | Arrow International, Inc. | 2017-03-31 | Traditional | PDF ↗ |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | Datascope Corp. | 2017-01-31 | Special | PDF ↗ |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | 2015-07-02 | Special | PDF ↗ |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | Datascope Corp. | 2013-12-12 | Special | PDF ↗ |
| K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES | Datascope Corp., Cardiac Assist Division | 2012-09-06 | Special | PDF ↗ |
| K120868 | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER | Datascope Corp., Cardiac Assist Division | 2012-04-20 | Special | PDF ↗ |
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 | Special | PDF ↗ |
| K112327 | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-09 | Special | PDF ↗ |
| K091449 | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 | Datascope Corp., Cardiac Assist Division | 2009-06-18 | Special | PDF ↗ |
| K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | Insightra Medical, Inc. | 2009-01-12 | Traditional | PDF ↗ |
| K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | Abiomed, Inc. | 2007-12-13 | Traditional | PDF ↗ |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | Datascope Corp. | 2007-01-05 | Special | PDF ↗ |
| K062582 | SUPRACOR BALLOON CATHETER | Abiomed, Inc. | 2006-12-14 | Traditional | PDF ↗ |
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | Arrow Intl., Inc. | 2006-04-06 | Special | PDF ↗ |
| K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES | Datascope Corp. | 2004-06-07 | Special | PDF ↗ |
| K040801 | INTRA-AORTIC BALLOON (IAB) | Arrow Intl., Inc. | 2004-05-06 | Special | PDF ↗ |
| K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX | Datascope Corp. | 2003-08-11 | Abbreviated | PDF ↗ |
| K031569 | DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX | Datascope Corp. | 2003-06-10 | Special | PDF ↗ |
| K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 | Arrow Intl., Inc. | 2002-06-06 | Special | PDF ↗ |
| K020257 | DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S | Datascope Corp. | 2002-04-24 | Traditional | PDF ↗ |
| K013326 | MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B | Datascope Corp. | 2001-11-02 | Special | PDF ↗ |
| K002256 | ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP | Arrow Intl., Inc. | 2001-05-03 | Traditional | PDF ↗ |
| K010330 | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U | Arrow Intl., Inc. | 2001-03-02 | Special | PDF ↗ |
| K003598 | DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 | Datascope Corp. | 2000-12-21 | Special | PDF ↗ |
| K002949 | MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC | Datascope Corp. | 2000-10-20 | Special | PDF ↗ |
| K000729 | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL | Arrow Intl., Inc. | 2000-05-19 | Special | PDF ↗ |
| K994157 | DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 | Datascope Corp. | 2000-03-13 | Traditional | PDF ↗ |
| K993966 | 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER | Arrow Intl., Inc. | 2000-02-18 | Special | PDF ↗ |
| K983866 | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP | Belmont Instrument Corp. | 2000-01-06 | Traditional | PDF ↗ |
| K981660 | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters | C.R. Bard, Inc. | 1998-10-16 | Traditional | PDF ↗ |
| K982538 | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP | Belmont Instrument Corp. | 1998-10-02 | Special | PDF ↗ |
| K970689 | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U | Arrow Intl., Inc. | 1998-06-04 | Traditional | PDF ↗ |
| K980850 | BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS | C.R. Bard, Inc. | 1998-06-03 | Traditional | PDF ↗ |
| K980780 | DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES | Datascope Corp. | 1998-05-29 | Traditional | PDF ↗ |
| K980385 | DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES | Datascope Corp. | 1998-05-01 | Traditional | PDF ↗ |
| K973962 | BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS | C.R. Bard, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K974247 | 40 CC GRANDE | Boston Scientific Corp | 1998-02-10 | Traditional | PDF ↗ |
| K965209 | ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) | Arrow Intl., Inc. | 1998-01-23 | Traditional | PDF ↗ |
| K963865 | 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S | Arrow Intl., Inc. | 1997-09-16 | Traditional | PDF ↗ |
| K972113 | 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL | Boston Scientific Corp | 1997-09-02 | Traditional | PDF ↗ |
| K971673 | 40 CC SUMO | Boston Scientific Corp | 1997-08-05 | Traditional | PDF ↗ |
| K965236 | SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) | Datascope Corp. | 1997-07-01 | Traditional | PDF ↗ |
| K963920 | 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, | Arrow Intl., Inc. | 1997-06-17 | Traditional | PDF ↗ |
| K964987 | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 | Datascope Corp. | 1997-03-17 | Traditional | PDF ↗ |
| K963104 | 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM | Arrow Intl., Inc. | 1997-02-04 | Traditional | PDF ↗ |
| K961509 | INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED | Datascope Corp. | 1996-11-15 | Traditional | PDF ↗ |
| K963187 | MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C | Boston Scientific Corp | 1996-11-04 | Traditional | PDF ↗ |
| K962177 | BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT | C.R. Bard, Inc. | 1996-09-04 | Traditional | PDF ↗ |
| K961358 | ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER | Arrow Intl., Inc. | 1996-07-02 | Traditional | PDF ↗ |
| K960713 | 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) | Arrow Intl., Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K960166 | PERCOR STAT-DL 9.5 FR. 34 & 40CC | Datascope Corp. | 1996-04-24 | Traditional | PDF ↗ |
| K954431 | PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS | Boston Scientific Corp | 1996-01-11 | Traditional | PDF ↗ |
| K952576 | TRANSPORT CART | Belmont Instrument Corp. | 1995-12-26 | Traditional | PDF ↗ |
| K952221 | BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 | Boston Scientific Corp | 1995-08-11 | Traditional | PDF ↗ |
| K950687 | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) | Belmont Instrument Corp. | 1995-05-24 | Traditional | PDF ↗ |
| K945230 | ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON | Arrow Intl., Inc. | 1995-05-09 | Traditional | PDF ↗ |
| K940298 | BSC/CA MODEL 940 IAB | Boston Scientific Corp | 1995-04-06 | Traditional | PDF ↗ |
| K943919 | 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER | Boston Scientific Corp | 1995-03-23 | Traditional | PDF ↗ |
| K942454 | DATASCOPE 95 AND 97 IAB PUMP CONSOLE | Datascope Corp. | 1995-02-24 | Traditional | PDF ↗ |
| K935184 | REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING | St. Jude Medical, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K944460 | DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD | Datascope Corp. | 1994-12-09 | Traditional | PDF ↗ |
| K936232 | BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER | Boston Scientific Corp | 1994-10-14 | Traditional | PDF ↗ |
| K940231 | INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION | Datascope Corp. | 1994-09-13 | Traditional | PDF ↗ |
| K940178 | PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION | Datascope Corp. | 1994-08-09 | Traditional | PDF ↗ |
| K932268 | MODIFICATIONS TO INTRA-AORTIC BALLOONS | Kontron Instruments, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K925248 | MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS | Kontron Instruments, Inc. | 1993-09-27 | Traditional | PDF ↗ |
| K926000 | 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER | Boston Scientific Corp | 1993-08-30 | Traditional | PDF ↗ |
| K911000 | PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON | Datascope Corp. | 1993-08-25 | Traditional | PDF ↗ |
| K914802 | DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL | Datascope Corp. | 1993-08-25 | Traditional | PDF ↗ |
| K920427 | PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON | Datascope Corp. | 1993-08-03 | Traditional | PDF ↗ |
| K905663 | PEDIATRIC INTRA-AORTIC BALLOON CATHETERS | Datascope Corp. | 1993-08-02 | Traditional | PDF ↗ |
| K922235 | SYSTEM 97 | Datascope Corp. | 1993-04-27 | Traditional | PDF ↗ |
| K924382 | BARD(R) INTRA AORTIC BALLOON | C.R. Bard, Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K921638 | SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE | Datascope Corp. | 1993-02-10 | Traditional | PDF ↗ |
| K915580 | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP | Belmont Instrument Corp. | 1992-10-30 | Traditional | PDF ↗ |
| K912629 | DATASCOPE SYSTEM 95 | Datascope Corp. | 1992-03-11 | Traditional | PDF ↗ |
| K913847 | SYSTEM 90 AND SYSTEM 90T | Datascope Corp. | 1992-03-11 | Traditional | PDF ↗ |
| K910997 | DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON | Datascope Corp. | 1991-11-05 | Traditional | PDF ↗ |
| K905313 | KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II | Kontron Instruments, Inc. | 1991-06-19 | Traditional | PDF ↗ |
| K905056 | PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT | Datascope Corp. | 1991-06-11 | Traditional | PDF ↗ |
| K903917 | COMPACT MONITOR SMK 210,211,230,231,240 | Ppg Hellige B.V. | 1991-01-18 | Traditional | PDF ↗ |
| K903344 | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) | Kontron Instruments, Inc. | 1991-01-15 | Traditional | PDF ↗ |
| K903930 | DATASCOPE PERCOR STAT DL 10.5 FR 50CC | Datascope Corp. | 1990-11-16 | Traditional | PDF ↗ |
| K904414 | DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS | Datascope Corp. | 1990-10-22 | Traditional | PDF ↗ |
| K903867 | DATASCOPE PERCOR STAT DL 10.5 FR 40CC | Datascope Corp. | 1990-10-19 | Traditional | PDF ↗ |
| K903892 | DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL | Datascope Corp. | 1990-10-19 | Traditional | PDF ↗ |
| K904018 | DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL | Datascope Corp. | 1990-10-19 | Traditional | PDF ↗ |
| K903769 | PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON | Datascope Corp. | 1990-10-19 | Traditional | PDF ↗ |
| K903893 | DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL | Datascope Corp. | 1990-10-19 | Traditional | PDF ↗ |
| K903736 | DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL | Datascope Corp. | 1990-10-09 | Traditional | PDF ↗ |
| K902057 | PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG | Datascope Corp. | 1990-09-25 | Traditional | PDF ↗ |
Product code DSP · Class II · Cardiovascular. Data: openFDA.