Panels › Cardiovascular › Product code DSP · Class 2
System, Balloon, Intra-Aortic And Control
Regulation 870.3535
0510(k)s in 12 months (162 all time)
7recalls in 12 months (194 all time)
181recalls that name a 510(k)
Top companies in DSP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2025 | K250542 | AC3 Range Intra-Aortic Balloon Pump Arrow International, LLC | DSP |
| Aug 30, 2023 | K232343 | AC3 Series IABP Arrow International, LLC | DSP |
| May 27, 2020 | K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP Arrow International, Inc. | DSP |
| Apr 9, 2020 | K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Arrow International, Inc. | DSP |
| Nov 12, 2019 | K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) Arrow International, Teleflex | DSP |
| Jun 28, 2019 | K190101 | UltraFlex IAB Arrow International, Inc. | DSP |
| Jun 13, 2019 | K190117 | Fiberoptix IAB Arrow International, Inc. | DSP |
| May 31, 2018 | K181122 | CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp. | DSP |
| Oct 12, 2017 | K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump Datascope Corp. | DSP |
| Mar 31, 2017 | K162820 | AC3 Series IABP System Arrow International, Inc. | DSP |
| Jan 31, 2017 | K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp. | DSP |
| Jul 2, 2015 | K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Datascope Corp. | DSP |
| Dec 12, 2013 | K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES Datascope Corp. | DSP |
| Sep 6, 2012 | K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES Datascope Corp., Cardiac Assist Division | DSP |
| Apr 20, 2012 | 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 | DSP |
| Sep 15, 2011 | K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC | DSP |
| Sep 9, 2011 | K112327 | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES Cardiac Assist, Maquet Cardiovascular, LLC | DSP |
| Jun 18, 2009 | K091449 | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 Datascope Corp., Cardiac Assist Division | DSP |
| Jan 12, 2009 | K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 Insightra Medical, Inc. | DSP |
| Dec 13, 2007 | K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE Abiomed, Inc. | DSP |
| Jan 5, 2007 | K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM Datascope Corp. | DSP |
| Dec 14, 2006 | K062582 | SUPRACOR BALLOON CATHETER Abiomed, Inc. | DSP |
| Apr 6, 2006 | K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES Arrow Intl., Inc. | DSP |
| Jun 7, 2004 | K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES Datascope Corp. | DSP |
| May 6, 2004 | K040801 | INTRA-AORTIC BALLOON (IAB) Arrow Intl., Inc. | DSP |
| Aug 11, 2003 | K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX Datascope Corp. | DSP |
| Jun 10, 2003 | K031569 | DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX Datascope Corp. | DSP |
| Jun 6, 2002 | K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 Arrow Intl., Inc. | DSP |
| Apr 24, 2002 | 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. | DSP |
| Nov 2, 2001 | K013326 | MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B Datascope Corp. | DSP |
| May 3, 2001 | K002256 | ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP Arrow Intl., Inc. | DSP |
| Mar 2, 2001 | K010330 | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U Arrow Intl., Inc. | DSP |
| Dec 21, 2000 | K003598 | DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 Datascope Corp. | DSP |
| Oct 20, 2000 | K002949 | MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC Datascope Corp. | DSP |
| May 19, 2000 | K000729 | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL Arrow Intl., Inc. | DSP |
| Mar 13, 2000 | K994157 | DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 Datascope Corp. | DSP |
| Feb 18, 2000 | K993966 | 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER Arrow Intl., Inc. | DSP |
| Jan 6, 2000 | K983866 | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP Belmont Instrument Corp. | DSP |
| Oct 16, 1998 | K981660 | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters C.R. Bard, Inc. | DSP |
| Oct 2, 1998 | K982538 | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP Belmont Instrument Corp. | DSP |
| Jun 4, 1998 | K970689 | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U Arrow Intl., Inc. | DSP |
| Jun 3, 1998 | K980850 | BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS C.R. Bard, Inc. | DSP |
| May 29, 1998 | K980780 | DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES Datascope Corp. | DSP |
| May 1, 1998 | K980385 | DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES Datascope Corp. | DSP |
| Feb 19, 1998 | K973962 | BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS C.R. Bard, Inc. | DSP |
| Feb 10, 1998 | K974247 | 40 CC GRANDE Boston Scientific Corp | DSP |
| Jan 23, 1998 | K965209 | ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) Arrow Intl., Inc. | DSP |
| Sep 16, 1997 | K963865 | 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S Arrow Intl., Inc. | DSP |
| Sep 2, 1997 | K972113 | 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL Boston Scientific Corp | DSP |
| Aug 5, 1997 | K971673 | 40 CC SUMO Boston Scientific Corp | DSP |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.