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 |
|---|---|---|---|
| Sep 14, 1990 | K892222 | 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Aug 17, 1990 | K896497 | PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON Datascope Corp. | DSP |
| Apr 19, 1990 | K900281 | SERIES 3001 IABP Boston Scientific Corp | DSP |
| Apr 10, 1990 | K895433 | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS Aries Medical, Inc. | DSP |
| Mar 6, 1990 | K896920 | SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER Boston Scientific Corp | DSP |
| Feb 12, 1990 | K896597 | THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. Boston Scientific Corp | DSP |
| Feb 5, 1990 | K896430 | PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI Datascope Corp. | DSP |
| Sep 26, 1989 | K894942 | SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER Boston Scientific Corp | DSP |
| Sep 20, 1989 | K892799 | 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Sep 20, 1989 | K892798 | 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Sep 20, 1989 | K892797 | 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Sep 13, 1989 | K892878 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 Kontron Instruments, Inc. | DSP |
| Jun 20, 1989 | K893243 | INTRA AORTIC BALLOON Datascope Corp. | DSP |
| Mar 20, 1989 | K882508 | 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON Kontron Instruments, Inc. | DSP |
| Mar 20, 1989 | K882274 | 10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC Kontron Instruments, Inc. | DSP |
| Jun 10, 1988 | K880289 | DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL Datascope Corp. | DSP |
| May 18, 1988 | K875036 | INTRA-AORTIC BALLOON PUMP MODEL KAAT Kontron Instruments, Inc. | DSP |
| Apr 1, 1988 | K874816 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 Kontron Instruments, Inc. | DSP |
| Jun 19, 1987 | K864994 | 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER Aries Medical, Inc. | DSP |
| Jun 19, 1987 | K864537 | 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER Aries Medical, Inc. | DSP |
| May 12, 1987 | K864568 | 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER Aries Medical, Inc. | DSP |
| May 12, 1987 | K864567 | 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER Aries Medical, Inc. | DSP |
| Jan 16, 1987 | K863185 | 40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON Aries Medical, Inc. | DSP |
| Jan 14, 1987 | K863219 | SYSTEM 90 TRANSPORT Datascope Corp. | DSP |
| Oct 1, 1986 | K860638 | NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| May 9, 1986 | K855102 | MONARK 869 ERGOMETER Equilibrated Bio Systems, Inc. | DSP |
| May 7, 1986 | K860427 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT Kontron Instruments, Inc. | DSP |
| Jan 22, 1986 | K853062 | INTRA-AORTIC BALLOON PUMP MODEL K2000 Kontron Instruments, Inc. | DSP |
| Dec 11, 1985 | K840367 | PRESSURE TRIGGER MOD OF SMEC INTRA-AORT Smec, Inc. | DSP |
| Aug 22, 1985 | K850482 | DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO Datascope Corp. | DSP |
| Feb 20, 1985 | K844220 | ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO Aries Medical, Inc. | DSP |
| Feb 8, 1985 | K833828 | PERCOR 9.5 FR IAB ON DATASCOPE CO2 Datascope Corp. | DSP |
| Feb 8, 1985 | K831235 | IABP #90 SYSTEM Datascope Corp. | DSP |
| Feb 1, 1985 | K840037 | MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC Smec, Inc. | DSP |
| Oct 13, 1984 | K832753 | PERCUTANEOUS BALLOON Smec, Inc. | DSP |
| May 16, 1984 | K833632 | ARIES MEDICAL MODEL 700 Aries Medical, Inc. | DSP |
| Nov 2, 1983 | K831397 | FRENCH INTRA-AORTIC 9.5 BALLOON ON KON Datascope Corp. | DSP |
| Nov 2, 1983 | K831307 | PECOR 8.5 FRENCH IAB ON A DATASCOPE Datascope Corp. | DSP |
| Apr 27, 1983 | K830411 | MINISCOPE MS-2 Jedmed Instrument Co. | DSP |
| Apr 27, 1983 | K830410 | EK COMBI MSG-1 Jedmed Instrument Co. | DSP |
| Feb 18, 1983 | K823739 | INTRA-AORTIC BALLOON SYSTEM Smec, Inc. | DSP |
| Jan 24, 1983 | K823342 | PERCOR INTRA-AORTIC BALLOON INSERTION Datascope Corp. | DSP |
| Dec 21, 1982 | K821951 | DATASCOPE MODEL 83 IABP SYSTEM Datascope Corp. | DSP |
| Dec 15, 1982 | K823177 | SMEC BALLOON SYSTEM Smec, Inc. | DSP |
| Oct 18, 1982 | K820882 | PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC Datascope Corp. | DSP |
| Aug 19, 1982 | K821065 | DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL Datascope Corp. | DSP |
| Jul 2, 1982 | K813355 | MODIFICATION OF THE PERCUTAN-BALLOON Smec, Inc. | DSP |
| Apr 29, 1982 | K820166 | ADAPTATION OF KANTRON 40 CC. PDLIAB Kontron Instruments, Inc. | DSP |
| Mar 31, 1982 | K813182 | DATASCOPE MODIFIED #82 IABP SYSTEM Datascope Corp. | DSP |
| Dec 2, 1981 | K813023 | FUKUDA DENSHI CARDIMAX FK-11 Brentwood Instruments, Inc. | DSP |
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