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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K892222 | 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON | Kontron Instruments, Inc. | 1990-09-14 | Traditional | PDF ↗ |
| K896497 | PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON | Datascope Corp. | 1990-08-17 | Traditional | PDF ↗ |
| K900281 | SERIES 3001 IABP | Boston Scientific Corp | 1990-04-19 | Traditional | PDF ↗ |
| K895433 | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS | Aries Medical, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K896920 | SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER | Boston Scientific Corp | 1990-03-06 | Traditional | PDF ↗ |
| K896597 | THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. | Boston Scientific Corp | 1990-02-12 | Traditional | PDF ↗ |
| K896430 | PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI | Datascope Corp. | 1990-02-05 | Traditional | PDF ↗ |
| K894942 | SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER | Boston Scientific Corp | 1989-09-26 | Traditional | PDF ↗ |
| K892799 | 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | Kontron Instruments, Inc. | 1989-09-20 | Traditional | PDF ↗ |
| K892797 | 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | Kontron Instruments, Inc. | 1989-09-20 | Traditional | PDF ↗ |
| K892798 | 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | Kontron Instruments, Inc. | 1989-09-20 | Traditional | PDF ↗ |
| K892878 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 | Kontron Instruments, Inc. | 1989-09-13 | Traditional | PDF ↗ |
| K893243 | INTRA AORTIC BALLOON | Datascope Corp. | 1989-06-20 | Traditional | PDF ↗ |
| K882274 | 10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC | Kontron Instruments, Inc. | 1989-03-20 | Traditional | PDF ↗ |
| K882508 | 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON | Kontron Instruments, Inc. | 1989-03-20 | Traditional | PDF ↗ |
| K880289 | DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL | Datascope Corp. | 1988-06-10 | Traditional | PDF ↗ |
| K875036 | INTRA-AORTIC BALLOON PUMP MODEL KAAT | Kontron Instruments, Inc. | 1988-05-18 | Traditional | PDF ↗ |
| K874816 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 | Kontron Instruments, Inc. | 1988-04-01 | Traditional | PDF ↗ |
| K864537 | 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER | Aries Medical, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K864994 | 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER | Aries Medical, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K864567 | 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER | Aries Medical, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K864568 | 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER | Aries Medical, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K863185 | 40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON | Aries Medical, Inc. | 1987-01-16 | Traditional | PDF ↗ |
| K863219 | SYSTEM 90 TRANSPORT | Datascope Corp. | 1987-01-14 | Traditional | PDF ↗ |
| K860638 | NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON | Kontron Instruments, Inc. | 1986-10-01 | Traditional | PDF ↗ |
| K855102 | MONARK 869 ERGOMETER | Equilibrated Bio Systems, Inc. | 1986-05-09 | Traditional | PDF ↗ |
| K860427 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT | Kontron Instruments, Inc. | 1986-05-07 | Traditional | PDF ↗ |
| K853062 | INTRA-AORTIC BALLOON PUMP MODEL K2000 | Kontron Instruments, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K840367 | PRESSURE TRIGGER MOD OF SMEC INTRA-AORT | Smec, Inc. | 1985-12-11 | Traditional | PDF ↗ |
| K850482 | DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO | Datascope Corp. | 1985-08-22 | Traditional | PDF ↗ |
| K844220 | ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO | Aries Medical, Inc. | 1985-02-20 | Traditional | PDF ↗ |
| K833828 | PERCOR 9.5 FR IAB ON DATASCOPE CO2 | Datascope Corp. | 1985-02-08 | Traditional | PDF ↗ |
| K831235 | IABP #90 SYSTEM | Datascope Corp. | 1985-02-08 | Traditional | PDF ↗ |
| K840037 | MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC | Smec, Inc. | 1985-02-01 | Traditional | PDF ↗ |
| K832753 | PERCUTANEOUS BALLOON | Smec, Inc. | 1984-10-13 | Traditional | PDF ↗ |
| K833632 | ARIES MEDICAL MODEL 700 | Aries Medical, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K831307 | PECOR 8.5 FRENCH IAB ON A DATASCOPE | Datascope Corp. | 1983-11-02 | Traditional | PDF ↗ |
| K831397 | FRENCH INTRA-AORTIC 9.5 BALLOON ON KON | Datascope Corp. | 1983-11-02 | Traditional | PDF ↗ |
| K830410 | EK COMBI MSG-1 | Jedmed Instrument Co. | 1983-04-27 | Traditional | PDF ↗ |
| K830411 | MINISCOPE MS-2 | Jedmed Instrument Co. | 1983-04-27 | Traditional | PDF ↗ |
| K823739 | INTRA-AORTIC BALLOON SYSTEM | Smec, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K823342 | PERCOR INTRA-AORTIC BALLOON INSERTION | Datascope Corp. | 1983-01-24 | Traditional | PDF ↗ |
| K821951 | DATASCOPE MODEL 83 IABP SYSTEM | Datascope Corp. | 1982-12-21 | Traditional | PDF ↗ |
| K823177 | SMEC BALLOON SYSTEM | Smec, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K820882 | PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC | Datascope Corp. | 1982-10-18 | Traditional | PDF ↗ |
| K821065 | DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL | Datascope Corp. | 1982-08-19 | Traditional | PDF ↗ |
| K813355 | MODIFICATION OF THE PERCUTAN-BALLOON | Smec, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K820166 | ADAPTATION OF KANTRON 40 CC. PDLIAB | Kontron Instruments, Inc. | 1982-04-29 | Traditional | PDF ↗ |
| K813182 | DATASCOPE MODIFIED #82 IABP SYSTEM | Datascope Corp. | 1982-03-31 | Traditional | PDF ↗ |
| K813023 | FUKUDA DENSHI CARDIMAX FK-11 | Brentwood Instruments, Inc. | 1981-12-02 | Traditional | PDF ↗ |
| K811372 | MODEL 84 TRANSPORT SYSTEM | Datascope Corp. | 1981-08-03 | Traditional | PDF ↗ |
| K810297 | DATASCOPE PERCOR=DL DUAL-LUMEN INTRA | Datascope Corp. | 1981-05-06 | Traditional | PDF ↗ |
| K802924 | KONTRON PERCUTAEOUS DOUBLE-LUMEN | Avco Medical Products | 1981-03-11 | Traditional | PDF ↗ |
| K801601 | DATASCOPE/AVCO CONNECTOR | Datascope Corp. | 1981-01-13 | Traditional | PDF ↗ |
| K802167 | PERCOR DATASCOPE INTRA-AORTIC BALLOON | Datascope Corp. | 1981-01-13 | Traditional | PDF ↗ |
| K790755 | SMEC BALLOON CANNULA | Smec, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K790775 | INTRA-AORTIC BALLOON, TYPE S | Datascope Corp. | 1979-10-01 | Traditional | PDF ↗ |
| K790241 | INTRA-AORTIC BALLOON-PUMP | Avco Medical Products | 1979-02-23 | Traditional | PDF ↗ |
| K781848 | PUMP, BALLOON MODEL 10 | Avco Medical Products | 1979-01-23 | Traditional | PDF ↗ |
| K780280 | BALLOON PUMP | Datascope Corp. | 1978-03-15 | Traditional | PDF ↗ |
| K770821 | PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT | Avco Medical Products | 1977-05-06 | Traditional | PDF ↗ |
| K760695 | TAMARI-KAPLITT | Yehuda Tamari | 1976-10-06 | Traditional | PDF ↗ |
Product code DSP · Class II · Cardiovascular. Data: openFDA.