FDA.reportPublic FDA data

Denny Kouri Kouri

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070632183007063218Denny Kouri Kouri1N2027-01-01ONE EDWARDS WAY Irvine CA US 92614
30063799103006379910Denny Kouri Kouri1N2026-01-01One Edwards Way Irvine CA US 92614

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1100901251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
1100901063643663P230013Edwards EVOQUE Tricuspid Valve Replacement SystemNPW2024-02-01
1100901875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
1100901675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
1100901356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
1100901430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
1100901156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1100901890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
1511011832023475K140312EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEMDXN2014-06-13
1511011614207012K122381NEXFIN MODEL 2DXN2013-04-22
1511011674528698K101123NEXFIN MODEL 2DXN2010-10-28
1511011035581695K072049CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICSDXN2007-11-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN42014-06-13
LWR22017-06-29
NPT22015-06-17
NKM 12022-09-14
NPV 12020-08-31
DYE11991-09-26