Atlas FDA

DRN

34 FDA 510(k) clearances · Product code

107 daysmedian time to decision
294 days90th percentile
34clearances measured

FDA profile

Official device name
Device, Counter-Pulsating, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5225
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2002: 16 · 2003: 16 · 2004: 6 · 2005: 6 · 2006: 2 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Pression Wave PRO External Counter-Pulsation System (K250756)Pression, Inc.2025-12-22
External Counterpulsation System, Soulaire (K202108)Vamed Medical Instrument Co., Ltd.2020-08-28
Enhanced External Counter Pulsation Device Plus Omay-A (K191955)Omay(Guangzhou)Med Technologies Co., Ltd.2020-08-05
External Counterpulsation System (K190683)Vamed Medical Instrument Co., Ltd.2019-09-10
Pure Flow External Counter-Pulsation Device (K173483)Xtreem Pulse, LLC2018-05-30
Renew NCP-5 External Counterpulsation System (K152115)Stage 2 Innovations2015-12-17
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (K130439)Chongqing Psk Sci-Tech Development Co., Ltd.2013-12-12
CIRCULATOR BOOT (K082134)Circulator Boot Corp.2009-05-07
GENESIS ECP (K081359)Scottcare Corporation2008-05-29
ECP HEALTH SYSTEM, MODEL 2005 (K052611)Ecp Health, Inc.2006-04-26
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (K050172)Cardiomedics, Inc.2005-03-31
ACS MODEL NCP-2 (K042413)Applied Cardiac Systems2004-12-09
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY (K033617)Vasomedical, Inc.2004-03-01
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V (K033657)Living Data Technologies Corporation2003-12-19
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP (K030587)S-Tct Health, Inc.2003-05-30
CPCA2000 COUNTERPULSATION SYSTEM (K030532)Cpca2000, Inc.2003-03-14
ANGIONEW-IV (K023701)Living Data Technologies Corporation2003-01-30
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE (K021340)External Counterpulsation Lab2003-01-30
SOLA, COUNTER-PULSATION, MODEL SECP-S (K022078)Sola Medical Devices, LLC2003-01-10
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (K023427)Cardiomedics, Inc.2003-01-07
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE (K023016)Nicore Equipment & Leasing, Inc.2002-12-04
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (K022107)Cardiomedics, Inc.2002-08-08
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER (K020857)Vasomedical, Inc.2002-06-14
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE (K012141)External Counterpulsation Lab2001-10-25
CARDIOMEDICS ECP SYSTEM (K010261)Cardiomedics, Inc.2001-02-28
EECP THERAPY SYSTEM, MODEL TS3 (K003469)Vasomedical, Inc.2000-12-06
NICORE MODEL ESP -1 (K980937)Nicore Equipment & Leasing, Inc.2000-09-15
THE CIRCULATOR BOOT (K971026)Circulator Boot Corp.1997-08-14
VASOGENICS EECP-MC2 (K940264)Vasogenics, Inc.1995-02-23
STONY BROOK MODEL EECP-MC1 (K882401)Stony Brook Trading and Development Corp.1989-03-03
CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM (K872034)Cardiomedics, Inc.1987-09-18
CIRCULATOR MINIBOOT (K833627)Circulator Boot Corp.1984-05-23
CARDIASSIST EXTERNAL COUNTERPULSATION (K792430)Cardiassist Corp.1980-01-23
THE CIRCULATOR BOOT (K792354)Circulator Boot Corp.1980-01-09

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