510(k) Report

Devices descending from K980937

6 later devices reach Nicore Model Esp -1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042413Acs Model NCP-2Applied Cardiac Systems20045—
+2K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc.20250—
+2K152115Renew NCP-5 External Counterpulsation SystemStage 2 Innovations20153—
+3K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC20182—
+4K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.20191—
+5K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.20200—