Lucy Tan

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30033062483003306248Lucy Tan1N2026-01-016035 Stoneridge Drive Pleasanton CA US 94588

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2165691268771950P170038CentriMag Circulatory Support SystemDSQ2019-12-06
2165691507592993K234118CentriMag™ Acute Circulatory Support SystemQNR2024-01-26
2165691542722552K222038CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support SystemQNR2022-12-08
2165692039803201K191557CentriMag Acute Circulatory Support SystemDWA2019-07-10
2165691518741954K152190Thoratec CentriMag Drainage (Venous) Cannula KitDWF2015-09-18
2165691393347401K152161Thoratec CentriMag Return (Arterial) Cannula KitDWF2015-09-18
2165691500468973K131179CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITORDWA2013-07-18
2165691172450858K110983CENTRIMAG DRAINAGE CANNULA KITDWF2011-06-20
2165691599155667K110980CENTRIMAG RETURN CANNULA KITDWF2011-06-20
2165692072640974K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORDWA2010-08-27
2165691765813038K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052KFM2009-10-08
2165691773473690K090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLESDWA2009-01-15
2165691251266729K083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLEDWA2008-11-26
2165691486203148K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100KFM2003-03-25
2165691850234297H070004
2165691237972502

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWA52019-07-10
DWF42015-09-18
QNR22024-01-26
KFM22009-10-08
DSQ 12019-12-06