Product Code: DSP
FDA class 2
21 CFR 870.3535
System, Balloon, Intra-Aortic And Control
Cardiovascular
The Intra-Aortic Balloon System and Control is a cardiovascular support device consisting of a balloon catheter placed in the descending aorta and an external control console that inflates and deflates the balloon in synchrony with the cardiac cycle to reduce cardiac workload and improve coronary perfusion. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSP and it is regulated under 21 CFR 870.3535 within the Cardiovascular medical specialty.
510(k)s
162
FEI Numbers
28
Registration Numbers
28
Unique Applicants
22
Years Active
48
Research product code DSP in seconds
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Basic Information
- Product Code
- DSP
- Device Class
- FDA class 2
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 162 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon Pump | Mar 26, 2025 | Substantially Equivalent | Arrow International, LLC |
| K232343 | AC3 Series IABP | Aug 30, 2023 | Substantially Equivalent | Arrow International, LLC |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | May 27, 2020 | Substantially Equivalent | Arrow International, Inc. |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | Apr 09, 2020 | Substantially Equivalent | Arrow International, Inc. |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Nov 12, 2019 | Substantially Equivalent | Arrow International, Teleflex |
| K190101 | UltraFlex IAB | Jun 28, 2019 | Substantially Equivalent | Arrow International, Inc. |
| K190117 | Fiberoptix IAB | Jun 13, 2019 | Substantially Equivalent | Arrow International, Inc. |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | May 31, 2018 | Substantially Equivalent | Datascope Corp. |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | Oct 12, 2017 | Substantially Equivalent | Datascope Corp. |
| K162820 | AC3 Series IABP System | Mar 31, 2017 | Substantially Equivalent | Arrow International, Inc. |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | Jan 31, 2017 | Substantially Equivalent | Datascope Corp. |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Jul 02, 2015 | Substantially Equivalent | Datascope Corp. |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | Dec 12, 2013 | Substantially Equivalent | Datascope Corp. |
| K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES | Sep 06, 2012 | Substantially Equivalent | Datascope Corp., Cardiac Assist Division |
| K120868 | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER | Apr 20, 2012 | Substantially Equivalent | Datascope Corp., Cardiac Assist Division |
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP | Sep 15, 2011 | Substantially Equivalent | Cardiac Assist, Maquet Cardiovascular, LLC |
| K112327 | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES | Sep 09, 2011 | Substantially Equivalent | Cardiac Assist, Maquet Cardiovascular, LLC |
| K091449 | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 | Jun 18, 2009 | Substantially Equivalent | Datascope Corp., Cardiac Assist Division |
| K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | Jan 12, 2009 | Substantially Equivalent | Insightra Medical, Inc. |
| K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | Dec 13, 2007 | Substantially Equivalent | Abiomed, Inc. |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | Jan 05, 2007 | Substantially Equivalent | Datascope Corp. |
| K062582 | SUPRACOR BALLOON CATHETER | Dec 14, 2006 | Substantially Equivalent | Abiomed, Inc. |
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | Apr 06, 2006 | Substantially Equivalent | Arrow Intl., Inc. |
| K041281 | DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES | Jun 07, 2004 | Substantially Equivalent | Datascope Corp. |
| K040801 | INTRA-AORTIC BALLOON (IAB) | May 06, 2004 | Substantially Equivalent | Arrow Intl., Inc. |
| K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX | Aug 11, 2003 | Substantially Equivalent | Datascope Corp. |
| K031569 | DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX | Jun 10, 2003 | Substantially Equivalent | Datascope Corp. |
| K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 | Jun 06, 2002 | Substantially Equivalent | Arrow Intl., Inc. |
| 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 | Apr 24, 2002 | Substantially Equivalent | Datascope Corp. |
| K013326 | MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B | Nov 02, 2001 | Substantially Equivalent | Datascope Corp. |
| K002256 | ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP | May 03, 2001 | Substantially Equivalent | Arrow Intl., Inc. |
| K010330 | ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U | Mar 02, 2001 | Substantially Equivalent | Arrow Intl., Inc. |
| K003598 | DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 | Dec 21, 2000 | Substantially Equivalent | Datascope Corp. |
| K002949 | MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC | Oct 20, 2000 | Substantially Equivalent | Datascope Corp. |
| K000729 | ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL | May 19, 2000 | Substantially Equivalent | Arrow Intl., Inc. |
| K994157 | DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 | Mar 13, 2000 | Substantially Equivalent | Datascope Corp. |
| K993966 | 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER | Feb 18, 2000 | Substantially Equivalent | Arrow Intl., Inc. |
| K983866 | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP | Jan 06, 2000 | Substantially Equivalent | Belmont Instrument Corp. |
| K981660 | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters | Oct 16, 1998 | Substantially Equivalent | C.R. Bard, Inc. |
| K982538 | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP | Oct 02, 1998 | Substantially Equivalent | Belmont Instrument Corp. |
| K970689 | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U | Jun 04, 1998 | Substantially Equivalent | Arrow Intl., Inc. |
| K980850 | BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS | Jun 03, 1998 | Substantially Equivalent | C.R. Bard, Inc. |
| K980780 | DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES | May 29, 1998 | Substantially Equivalent | Datascope Corp. |
| K980385 | DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES | May 01, 1998 | Substantially Equivalent | Datascope Corp. |
| K973962 | BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS | Feb 19, 1998 | Substantially Equivalent | C.R. Bard, Inc. |
| K974247 | 40 CC GRANDE | Feb 10, 1998 | Substantially Equivalent | Boston Scientific Corp |
| K965209 | ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) | Jan 23, 1998 | Substantially Equivalent | Arrow Intl., Inc. |
| K963865 | 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S | Sep 16, 1997 | Substantially Equivalent | Arrow Intl., Inc. |
| K972113 | 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL | Sep 02, 1997 | Substantially Equivalent | Boston Scientific Corp |
| K971673 | 40 CC SUMO | Aug 05, 1997 | Substantially Equivalent | Boston Scientific Corp |
| K965236 | SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) | Jul 01, 1997 | Substantially Equivalent | Datascope Corp. |
| K963920 | 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, | Jun 17, 1997 | Substantially Equivalent | Arrow Intl., Inc. |
| K964987 | DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 | Mar 17, 1997 | Substantially Equivalent | Datascope Corp. |
| K963104 | 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM | Feb 04, 1997 | Substantially Equivalent | Arrow Intl., Inc. |
| K961509 | INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED | Nov 15, 1996 | Substantially Equivalent | Datascope Corp. |
| K963187 | MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C | Nov 04, 1996 | Substantially Equivalent | Boston Scientific Corp |
| K962177 | BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT | Sep 04, 1996 | Substantially Equivalent | C.R. Bard, Inc. |
| K961358 | ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER | Jul 02, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K960713 | 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) | May 15, 1996 | Substantially Equivalent | Arrow Intl., Inc. |
| K960166 | PERCOR STAT-DL 9.5 FR. 34 & 40CC | Apr 24, 1996 | Substantially Equivalent | Datascope Corp. |
| K954431 | PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS | Jan 11, 1996 | Substantially Equivalent | Boston Scientific Corp |
| K952576 | TRANSPORT CART | Dec 26, 1995 | Substantially Equivalent | Belmont Instrument Corp. |
| K952221 | BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 | Aug 11, 1995 | Substantially Equivalent | Boston Scientific Corp |
| K950687 | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) | May 24, 1995 | Substantially Equivalent | Belmont Instrument Corp. |
| K945230 | ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON | May 09, 1995 | Substantially Equivalent | Arrow Intl., Inc. |
| K940298 | BSC/CA MODEL 940 IAB | Apr 06, 1995 | Substantially Equivalent | Boston Scientific Corp |
| K943919 | 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER | Mar 23, 1995 | Substantially Equivalent | Boston Scientific Corp |
| K942454 | DATASCOPE 95 AND 97 IAB PUMP CONSOLE | Feb 24, 1995 | Substantially Equivalent | Datascope Corp. |
| K935184 | REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING | Feb 10, 1995 | Substantially Equivalent | St. Jude Medical, Inc. |
| K944460 | DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD | Dec 09, 1994 | Substantially Equivalent | Datascope Corp. |
| K936232 | BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER | Oct 14, 1994 | Substantially Equivalent | Boston Scientific Corp |
| K940231 | INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION | Sep 13, 1994 | Substantially Equivalent | Datascope Corp. |
| K940178 | PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION | Aug 09, 1994 | Substantially Equivalent | Datascope Corp. |
| K932268 | MODIFICATIONS TO INTRA-AORTIC BALLOONS | Dec 15, 1993 | Substantially Equivalent | Kontron Instruments, Inc. |
| K925248 | MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS | Sep 27, 1993 | Substantially Equivalent | Kontron Instruments, Inc. |
| K926000 | 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER | Aug 30, 1993 | Substantially Equivalent | Boston Scientific Corp |
| K914802 | DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL | Aug 25, 1993 | Substantially Equivalent | Datascope Corp. |
| K911000 | PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON | Aug 25, 1993 | Substantially Equivalent | Datascope Corp. |
| K920427 | PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON | Aug 03, 1993 | Substantially Equivalent | Datascope Corp. |
| K905663 | PEDIATRIC INTRA-AORTIC BALLOON CATHETERS | Aug 02, 1993 | Substantially Equivalent | Datascope Corp. |
| K922235 | SYSTEM 97 | Apr 27, 1993 | Substantially Equivalent | Datascope Corp. |
| K924382 | BARD(R) INTRA AORTIC BALLOON | Apr 07, 1993 | Substantially Equivalent | C.R. Bard, Inc. |
| K921638 | SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE | Feb 10, 1993 | Substantially Equivalent | Datascope Corp. |
| K915580 | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP | Oct 30, 1992 | Substantially Equivalent | Belmont Instrument Corp. |
| K913847 | SYSTEM 90 AND SYSTEM 90T | Mar 11, 1992 | Substantially Equivalent | Datascope Corp. |
| K912629 | DATASCOPE SYSTEM 95 | Mar 11, 1992 | Substantially Equivalent | Datascope Corp. |
| K910997 | DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON | Nov 05, 1991 | Substantially Equivalent - Market after Inspection | Datascope Corp. |
| K905313 | KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II | Jun 19, 1991 | Substantially Equivalent | Kontron Instruments, Inc. |
| K905056 | PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT | Jun 11, 1991 | Substantially Equivalent | Datascope Corp. |
| K903917 | COMPACT MONITOR SMK 210,211,230,231,240 | Jan 18, 1991 | Substantially Equivalent | Ppg Hellige B.V. |
| K903344 | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) | Jan 15, 1991 | Substantially Equivalent | Kontron Instruments, Inc. |
| K903930 | DATASCOPE PERCOR STAT DL 10.5 FR 50CC | Nov 16, 1990 | Substantially Equivalent | Datascope Corp. |
| K904414 | DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS | Oct 22, 1990 | Substantially Equivalent | Datascope Corp. |
| K904018 | DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL | Oct 19, 1990 | Substantially Equivalent | Datascope Corp. |
| K903893 | DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL | Oct 19, 1990 | Substantially Equivalent | Datascope Corp. |
| K903892 | DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL | Oct 19, 1990 | Substantially Equivalent | Datascope Corp. |
| K903867 | DATASCOPE PERCOR STAT DL 10.5 FR 40CC | Oct 19, 1990 | Substantially Equivalent | Datascope Corp. |
| K903769 | PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON | Oct 19, 1990 | Substantially Equivalent | Datascope Corp. |
| K903736 | DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL | Oct 09, 1990 | Substantially Equivalent | Datascope Corp. |
| K902057 | PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG | Sep 25, 1990 | Substantially Equivalent | Datascope Corp. |
| K892222 | 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON | Sep 14, 1990 | Substantially Equivalent | Kontron Instruments, Inc. |
| K896497 | PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON | Aug 17, 1990 | Substantially Equivalent | Datascope Corp. |
| K900281 | SERIES 3001 IABP | Apr 19, 1990 | Substantially Equivalent | Boston Scientific Corp |
| K895433 | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS | Apr 10, 1990 | Substantially Equivalent | Aries Medical, Inc. |
| K896920 | SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER | Mar 06, 1990 | Substantially Equivalent | Boston Scientific Corp |
| K896597 | THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. | Feb 12, 1990 | Substantially Equivalent | Boston Scientific Corp |
| K896430 | PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI | Feb 05, 1990 | Substantially Equivalent | Datascope Corp. |
| K894942 | SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER | Sep 26, 1989 | Substantially Equivalent | Boston Scientific Corp |
| K892799 | 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | Sep 20, 1989 | Substantially Equivalent | Kontron Instruments, Inc. |
| K892798 | 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | Sep 20, 1989 | Substantially Equivalent | Kontron Instruments, Inc. |
| K892797 | 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | Sep 20, 1989 | Substantially Equivalent | Kontron Instruments, Inc. |
| K892878 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 | Sep 13, 1989 | Substantially Equivalent | Kontron Instruments, Inc. |
| K893243 | INTRA AORTIC BALLOON | Jun 20, 1989 | Substantially Equivalent | Datascope Corp. |
| K882508 | 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON | Mar 20, 1989 | Substantially Equivalent | Kontron Instruments, Inc. |
| K882274 | 10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC | Mar 20, 1989 | Substantially Equivalent | Kontron Instruments, Inc. |
| K880289 | DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL | Jun 10, 1988 | Substantially Equivalent | Datascope Corp. |
| K875036 | INTRA-AORTIC BALLOON PUMP MODEL KAAT | May 18, 1988 | Substantially Equivalent | Kontron Instruments, Inc. |
| K874816 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 | Apr 01, 1988 | Substantially Equivalent | Kontron Instruments, Inc. |
| K864994 | 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER | Jun 19, 1987 | Substantially Equivalent | Aries Medical, Inc. |
| K864537 | 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER | Jun 19, 1987 | Substantially Equivalent | Aries Medical, Inc. |
| K864568 | 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER | May 12, 1987 | Substantially Equivalent | Aries Medical, Inc. |
| K864567 | 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER | May 12, 1987 | Substantially Equivalent | Aries Medical, Inc. |
| K863185 | 40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON | Jan 16, 1987 | Substantially Equivalent | Aries Medical, Inc. |
| K863219 | SYSTEM 90 TRANSPORT | Jan 14, 1987 | Substantially Equivalent | Datascope Corp. |
| K860638 | NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON | Oct 01, 1986 | Substantially Equivalent | Kontron Instruments, Inc. |
| K855102 | MONARK 869 ERGOMETER | May 09, 1986 | Substantially Equivalent | Equilibrated Bio Systems, Inc. |
| K860427 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT | May 07, 1986 | Substantially Equivalent | Kontron Instruments, Inc. |
| K853062 | INTRA-AORTIC BALLOON PUMP MODEL K2000 | Jan 22, 1986 | Substantially Equivalent | Kontron Instruments, Inc. |
| K840367 | PRESSURE TRIGGER MOD OF SMEC INTRA-AORT | Dec 11, 1985 | Substantially Equivalent | Smec, Inc. |
| K850482 | DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO | Aug 22, 1985 | Substantially Equivalent | Datascope Corp. |
| K844220 | ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO | Feb 20, 1985 | Substantially Equivalent | Aries Medical, Inc. |
| K833828 | PERCOR 9.5 FR IAB ON DATASCOPE CO2 | Feb 08, 1985 | Substantially Equivalent | Datascope Corp. |
| K831235 | IABP #90 SYSTEM | Feb 08, 1985 | Substantially Equivalent | Datascope Corp. |
| K840037 | MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC | Feb 01, 1985 | Substantially Equivalent | Smec, Inc. |
| K832753 | PERCUTANEOUS BALLOON | Oct 13, 1984 | Substantially Equivalent | Smec, Inc. |
| K833632 | ARIES MEDICAL MODEL 700 | May 16, 1984 | Substantially Equivalent | Aries Medical, Inc. |
| K831397 | FRENCH INTRA-AORTIC 9.5 BALLOON ON KON | Nov 02, 1983 | Substantially Equivalent | Datascope Corp. |
| K831307 | PECOR 8.5 FRENCH IAB ON A DATASCOPE | Nov 02, 1983 | Substantially Equivalent | Datascope Corp. |
| K830411 | MINISCOPE MS-2 | Apr 27, 1983 | Substantially Equivalent | Jedmed Instrument Co. |
| K830410 | EK COMBI MSG-1 | Apr 27, 1983 | Substantially Equivalent | Jedmed Instrument Co. |
| K823739 | INTRA-AORTIC BALLOON SYSTEM | Feb 18, 1983 | Substantially Equivalent | Smec, Inc. |
| K823342 | PERCOR INTRA-AORTIC BALLOON INSERTION | Jan 24, 1983 | Substantially Equivalent | Datascope Corp. |
| K821951 | DATASCOPE MODEL 83 IABP SYSTEM | Dec 21, 1982 | Substantially Equivalent | Datascope Corp. |
| K823177 | SMEC BALLOON SYSTEM | Dec 15, 1982 | Substantially Equivalent | Smec, Inc. |
| K820882 | PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC | Oct 18, 1982 | Substantially Equivalent | Datascope Corp. |
| K821065 | DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL | Aug 19, 1982 | Substantially Equivalent | Datascope Corp. |
| K813355 | MODIFICATION OF THE PERCUTAN-BALLOON | Jul 02, 1982 | Substantially Equivalent | Smec, Inc. |
| K820166 | ADAPTATION OF KANTRON 40 CC. PDLIAB | Apr 29, 1982 | Substantially Equivalent | Kontron Instruments, Inc. |
| K813182 | DATASCOPE MODIFIED #82 IABP SYSTEM | Mar 31, 1982 | Substantially Equivalent | Datascope Corp. |
| K813023 | FUKUDA DENSHI CARDIMAX FK-11 | Dec 02, 1981 | Substantially Equivalent | Brentwood Instruments, Inc. |
| K811372 | MODEL 84 TRANSPORT SYSTEM | Aug 03, 1981 | Substantially Equivalent | Datascope Corp. |
| K810297 | DATASCOPE PERCOR=DL DUAL-LUMEN INTRA | May 06, 1981 | Substantially Equivalent | Datascope Corp. |
| K802924 | KONTRON PERCUTAEOUS DOUBLE-LUMEN | Mar 11, 1981 | Substantially Equivalent | Avco Medical Products |
| K802167 | PERCOR DATASCOPE INTRA-AORTIC BALLOON | Jan 13, 1981 | Substantially Equivalent | Datascope Corp. |
| K801601 | DATASCOPE/AVCO CONNECTOR | Jan 13, 1981 | Substantially Equivalent | Datascope Corp. |
| K790755 | SMEC BALLOON CANNULA | May 14, 1980 | Substantially Equivalent | Smec, Inc. |
| K790775 | INTRA-AORTIC BALLOON, TYPE S | Oct 01, 1979 | Substantially Equivalent | Datascope Corp. |
| K790241 | INTRA-AORTIC BALLOON-PUMP | Feb 23, 1979 | Substantially Equivalent | Avco Medical Products |
| K781848 | PUMP, BALLOON MODEL 10 | Jan 23, 1979 | Substantially Equivalent | Avco Medical Products |
| K780280 | BALLOON PUMP | Mar 15, 1978 | Substantially Equivalent | Datascope Corp. |
| K770821 | PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT | May 06, 1977 | Substantially Equivalent | Avco Medical Products |
| K760695 | TAMARI-KAPLITT | Oct 06, 1976 | Substantially Equivalent | Yehuda Tamari |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.