FDA 510(k) Applications for Medical Device Product Code: DRN (Device, Counter-Pulsating, External)

FDA 510(k) Applications for Medical Device Product Code "DRN"
(Device, Counter-Pulsating, External)

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

FDA 510(k) Applications for Medical Device Product Code "DRN" (Device, Counter-Pulsating, External)

FDA 510(k) Applications for Medical Device Product Code "DRN"
(Device, Counter-Pulsating, External)