FDA.reportPublic FDA data

Denny Kouri

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30172985883017298588Denny Kouri1N2027-01-01One Edwards Way Irvine CA US 92614
96158173003081151Denny Kouri1N2020-04-25ONE EDWARDS WAY Irvine CA US 92614

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3063451875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
3063451675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
3063451156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
573241749391495K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
573241200607658K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
573241349899943K833997CO-SET1984-04-17
573241308823316K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
573241994614558K821416DISPOSABLE BLOOD PRESSURE TRANSDUCERDRS1982-07-02
573241959202300K811399EDSLAB CLOSED INJECTATE DELIVERY SYSTEMKRB1981-06-09
573241926015187K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06DXC1981-02-04
3063451643867828K200258Edwards eSheath Introducer SetDYB2020-03-09
573241670155142K190130The ClearSight finger cuffsDXN2019-06-21
573241728602474K183413TruWave Disposable Pressure TransducerDXO2019-05-01
573241165928081K181684VAMP Plus Venous/Arterial Blood Management Protection SystemKRA2018-11-08
573242003304713K180275VAMP Optima closed blood sampling systemKRA2018-10-24
573241479686108K173586VAMP Venous/Arterial Blood Management Protection SystemKRA2018-04-05
573241329601746K171996TruWave Disposable Pressure TransducerDXO2017-10-23
573241539963573K161962VAMP Venous/Arterial Blood Management Protection SystemKRA2016-11-28
573241085157824K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformDXN2016-06-01
573241453790904K152980Flo Trac sensor, Volume View sensorDRS2016-01-19
573241251101753K142749TruWave Disposable Pressure TransducerDXO2015-01-18
573241173846042K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCERDXO2014-09-03
573241214141132
573241773855827
573242029800478
3063451591930772

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXO52019-05-01
KRA52018-11-08
DXN22019-06-21
DRS22016-01-19
DXC21983-09-29
NKM 12022-09-14
NPV 12020-08-31
DYB12020-03-09
NPT12015-06-17
KRB11981-06-09