ClearanceBrief
Panels › Cardiovascular › Product code DRN · Class 2

Device, Counter-Pulsating, External

Regulation 870.5225

1510(k)s in 12 months (34 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in DRN

Company510(k)sRecalls
Cardiomedics, Inc.51
Circulator Boot Corp.40
Vasomedical, Inc.30
External Counterpulsation Lab20
Living Data Technologies Corporation20
Nicore Equipment & Leasing, Inc.20
Vamed Medical Instrument Co., Ltd.20
Applied Cardiac Systems10
Cardiassist Corp.10
Chongqing Psk Sci-Tech Development Co., Ltd.10
Decided510(k)Device and applicantCode
Dec 22, 2025K250756Pression Wave PRO External Counter-Pulsation System
Pression, Inc.
DRN
Aug 28, 2020K202108External Counterpulsation System, Soulaire
Vamed Medical Instrument Co., Ltd., CN
DRN
Aug 5, 2020K191955Enhanced External Counter Pulsation Device Plus Omay-A
Omay(Guangzhou)Med Technologies Co., Ltd., CN
DRN
Sep 10, 2019K190683External Counterpulsation System
Vamed Medical Instrument Co., Ltd., CN
DRN
May 30, 2018K173483Pure Flow External Counter-Pulsation Device
Xtreem Pulse, LLC
DRN
Dec 17, 2015K152115Renew NCP-5 External Counterpulsation System
Stage 2 Innovations
DRN
Dec 12, 2013K130439EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
Chongqing Psk Sci-Tech Development Co., Ltd., CN
DRN
May 7, 2009K082134CIRCULATOR BOOT
Circulator Boot Corp.
DRN
May 29, 2008K081359GENESIS ECP
Scottcare Corporation
DRN
Apr 26, 2006K052611ECP HEALTH SYSTEM, MODEL 2005
Ecp Health, Inc.
DRN
Mar 31, 2005K050172CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
Cardiomedics, Inc.
DRN
Dec 9, 2004K042413ACS MODEL NCP-2
Applied Cardiac Systems
DRN
Mar 1, 2004K033617EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
Vasomedical, Inc.
DRN
Dec 19, 2003K033657MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
Living Data Technologies Corporation
DRN
May 30, 2003K030587EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
S-Tct Health, Inc.
DRN
Mar 14, 2003K030532CPCA2000 COUNTERPULSATION SYSTEM
Cpca2000, Inc.
DRN
Jan 30, 2003K023701ANGIONEW-IV
Living Data Technologies Corporation
DRN
Jan 30, 2003K021340AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
External Counterpulsation Lab, CN
DRN
Jan 10, 2003K022078SOLA, COUNTER-PULSATION, MODEL SECP-S
Sola Medical Devices, LLC
DRN
Jan 7, 2003K023427CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
Cardiomedics, Inc.
DRN
Dec 4, 2002K023016NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
Nicore Equipment & Leasing, Inc.
DRN
Aug 8, 2002K022107CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
Cardiomedics, Inc.
DRN
Jun 14, 2002K020857EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
Vasomedical, Inc.
DRN
Oct 25, 2001K012141AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
External Counterpulsation Lab, IL
DRN
Feb 28, 2001K010261CARDIOMEDICS ECP SYSTEM
Cardiomedics, Inc.
DRN
Dec 6, 2000K003469EECP THERAPY SYSTEM, MODEL TS3
Vasomedical, Inc.
DRN
Sep 15, 2000K980937NICORE MODEL ESP -1
Nicore Equipment & Leasing, Inc.
DRN
Aug 14, 1997K971026THE CIRCULATOR BOOT
Circulator Boot Corp.
DRN
Feb 23, 1995K940264VASOGENICS EECP-MC2
Vasogenics, Inc.
DRN
Mar 3, 1989K882401STONY BROOK MODEL EECP-MC1
Stony Brook Trading and Development Corp.
DRN
Sep 18, 1987K872034CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM
Cardiomedics, Inc.
DRN
May 23, 1984K833627CIRCULATOR MINIBOOT
Circulator Boot Corp.
DRN
Jan 23, 1980K792430CARDIASSIST EXTERNAL COUNTERPULSATION
Cardiassist Corp.
DRN
Jan 9, 1980K792354THE CIRCULATOR BOOT
Circulator Boot Corp.
DRN

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