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 |
|---|---|---|---|
| Jul 1, 1997 | K965236 | SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) Datascope Corp. | DSP |
| Jun 17, 1997 | K963920 | 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, Arrow Intl., Inc. | DSP |
| Mar 17, 1997 | K964987 | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 Datascope Corp. | DSP |
| Feb 4, 1997 | K963104 | 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM Arrow Intl., Inc. | DSP |
| Nov 15, 1996 | K961509 | INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED Datascope Corp. | DSP |
| Nov 4, 1996 | K963187 | MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C Boston Scientific Corp | DSP |
| Sep 4, 1996 | K962177 | BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT C.R. Bard, Inc. | DSP |
| Jul 2, 1996 | K961358 | ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER Arrow Intl., Inc. | DSP |
| May 15, 1996 | 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. | DSP |
| Apr 24, 1996 | K960166 | PERCOR STAT-DL 9.5 FR. 34 & 40CC Datascope Corp. | DSP |
| Jan 11, 1996 | K954431 | PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS Boston Scientific Corp | DSP |
| Dec 26, 1995 | K952576 | TRANSPORT CART Belmont Instrument Corp. | DSP |
| Aug 11, 1995 | K952221 | BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 Boston Scientific Corp | DSP |
| May 24, 1995 | K950687 | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) Belmont Instrument Corp. | DSP |
| May 9, 1995 | K945230 | ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON Arrow Intl., Inc. | DSP |
| Apr 6, 1995 | K940298 | BSC/CA MODEL 940 IAB Boston Scientific Corp | DSP |
| Mar 23, 1995 | K943919 | 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER Boston Scientific Corp | DSP |
| Feb 24, 1995 | K942454 | DATASCOPE 95 AND 97 IAB PUMP CONSOLE Datascope Corp. | DSP |
| Feb 10, 1995 | K935184 | REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING St. Jude Medical, Inc. | DSP |
| Dec 9, 1994 | K944460 | DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD Datascope Corp. | DSP |
| Oct 14, 1994 | K936232 | BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER Boston Scientific Corp | DSP |
| Sep 13, 1994 | K940231 | INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION Datascope Corp. | DSP |
| Aug 9, 1994 | K940178 | PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION Datascope Corp. | DSP |
| Dec 15, 1993 | K932268 | MODIFICATIONS TO INTRA-AORTIC BALLOONS Kontron Instruments, Inc. | DSP |
| Sep 27, 1993 | K925248 | MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS Kontron Instruments, Inc. | DSP |
| Aug 30, 1993 | K926000 | 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER Boston Scientific Corp | DSP |
| Aug 25, 1993 | K914802 | DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL Datascope Corp. | DSP |
| Aug 25, 1993 | K911000 | PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON Datascope Corp. | DSP |
| Aug 3, 1993 | K920427 | PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON Datascope Corp. | DSP |
| Aug 2, 1993 | K905663 | PEDIATRIC INTRA-AORTIC BALLOON CATHETERS Datascope Corp. | DSP |
| Apr 27, 1993 | K922235 | SYSTEM 97 Datascope Corp. | DSP |
| Apr 7, 1993 | K924382 | BARD(R) INTRA AORTIC BALLOON C.R. Bard, Inc. | DSP |
| Feb 10, 1993 | K921638 | SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE Datascope Corp. | DSP |
| Oct 30, 1992 | K915580 | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP Belmont Instrument Corp. | DSP |
| Mar 11, 1992 | K913847 | SYSTEM 90 AND SYSTEM 90T Datascope Corp. | DSP |
| Mar 11, 1992 | K912629 | DATASCOPE SYSTEM 95 Datascope Corp. | DSP |
| Nov 5, 1991 | K910997 | DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON Datascope Corp. | DSP |
| Jun 19, 1991 | K905313 | KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II Kontron Instruments, Inc. | DSP |
| Jun 11, 1991 | K905056 | PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT Datascope Corp. | DSP |
| Jan 18, 1991 | K903917 | COMPACT MONITOR SMK 210,211,230,231,240 Ppg Hellige B.V., DE | DSP |
| Jan 15, 1991 | K903344 | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) Kontron Instruments, Inc. | DSP |
| Nov 16, 1990 | K903930 | DATASCOPE PERCOR STAT DL 10.5 FR 50CC Datascope Corp. | DSP |
| Oct 22, 1990 | K904414 | DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS Datascope Corp. | DSP |
| Oct 19, 1990 | K904018 | DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL Datascope Corp. | DSP |
| Oct 19, 1990 | K903893 | DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL Datascope Corp. | DSP |
| Oct 19, 1990 | K903892 | DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL Datascope Corp. | DSP |
| Oct 19, 1990 | K903867 | DATASCOPE PERCOR STAT DL 10.5 FR 40CC Datascope Corp. | DSP |
| Oct 19, 1990 | K903769 | PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON Datascope Corp. | DSP |
| Oct 9, 1990 | K903736 | DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL Datascope Corp. | DSP |
| Sep 25, 1990 | K902057 | PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG Datascope Corp. | DSP |
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