FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K042413 |
APPLIED CARDIAC SYSTEMS |
ACS MODEL NCP-2 |
12/09/2004 |
K050172 |
CARDIOMEDICS, INC. |
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 |
03/31/2005 |
K022107 |
CARDIOMEDICS, INC. |
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 |
08/08/2002 |
K023427 |
CARDIOMEDICS, INC. |
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 |
01/07/2003 |
K010261 |
CARDIOMEDICS, INC. |
CARDIOMEDICS ECP SYSTEM |
02/28/2001 |
K130439 |
CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD |
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING |
12/12/2013 |
K082134 |
CIRCULATOR BOOT CORP. |
CIRCULATOR BOOT |
05/07/2009 |
K971026 |
CIRCULATOR BOOT CORP. |
THE CIRCULATOR BOOT |
08/14/1997 |
K030532 |
CPCA2000 INC |
CPCA2000 COUNTERPULSATION SYSTEM |
03/14/2003 |
K052611 |
ECP HEALTH INC. |
ECP HEALTH SYSTEM, MODEL 2005 |
04/26/2006 |
K021340 |
EXTERNAL COUNTERPULSATION LAB |
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE |
01/30/2003 |
K012141 |
EXTERNAL COUNTERPULSATION LAB |
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE |
10/25/2001 |
K023701 |
LIVING DATA TECHNOLOGIES CORPORATION |
ANGIONEW-IV |
01/30/2003 |
K033657 |
LIVING DATA TECHNOLOGIES CORPORATION |
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V |
12/19/2003 |
K980937 |
NICORE EQUIPMENT & LEASING, INC. |
NICORE MODEL ESP -1 |
09/15/2000 |
K023016 |
NICORE EQUIPMENT & LEASING, INC. |
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE |
12/04/2002 |
K191955 |
Omay(Guangzhou)Med Technologies Co., Ltd. |
Enhanced External Counter Pulsation Device Plus Omay-A |
08/05/2020 |
K030587 |
S-TCT HEALTH INC. |
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP |
05/30/2003 |
K081359 |
SCOTTCARE CORPORATION |
GENESIS ECP |
05/29/2008 |
K022078 |
SOLA MEDICAL DEVICES, LLC |
SOLA, COUNTER-PULSATION, MODEL SECP-S |
01/10/2003 |
K152115 |
Stage 2 Innovations |
Renew NCP-5 External Counterpulsation System |
12/17/2015 |
K190683 |
Vamed Medical Instrument Co., Ltd |
External Counterpulsation System |
09/10/2019 |
K202108 |
Vamed Medical Instrument Co., Ltd. |
External Counterpulsation System, Soulaire |
08/28/2020 |
K020857 |
VASOMEDICAL, INC. |
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER |
06/14/2002 |
K033617 |
VASOMEDICAL, INC. |
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY |
03/01/2004 |
K003469 |
VASOMEDICAL, INC. |
EECP THERAPY SYSTEM, MODEL TS3 |
12/06/2000 |
K173483 |
Xtreem Pulse, LLC |
Pure Flow External Counter-Pulsation Device |
05/30/2018 |