FDA.reportPublic FDA data

Celia Encinas

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96176013002534070Celia Encinas1N2026-01-011610 Landmark Rd San Diego CA US 92154

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
57931070994717P790017USCI DILATATION CATHETERLOX1980-03-24
57931091031584P200046Harmony™ TPV SystemNPV2021-03-26
57931544873900P170006AVALUS(TM) BIOPROSTHESISLWR2017-07-31
57931150969043P140017MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)NPV2015-01-27
57931343864551P130021MEDTRONIC COREVALVE SYSTEMNPT2014-01-17
57931598640776P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
57931783538380P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
57931814031394P100010ARCTIC FRONT CRYOCATHETER SYSTEMOAE2010-12-17
57931734968408P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEMLPB2003-04-17
57931929023127K994208AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354DTM2000-01-13
57931379164924K994171MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAEDWF2000-04-27
57931837660933K991066MADTRONIC DLP ARTERIAL CANNULAEDWF1999-09-14
57931810442292K984053BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMJXG1999-02-04
57931577748025K983799MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICLGWM1999-01-26
57931049149074K982755MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)CAC1998-08-20
57931962449088K981046MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118JXG1998-06-16
57931012416779K973760AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACEDTZ1998-02-18
57931233260970K973237CSS-CARDIOPLEGIA SAFETY SYSTEMDWB1998-04-27
57931576003066K973011BPX80 BIO-PUMP (BPX80)KFM1998-02-25
57931358774335K972894AUTOTRANSFUSION APPARTUS (AUTOLOG)CAC1998-04-27
57931839638185K971105MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEMDTN1997-07-11
57931086761684K960356POSTERIOR ANNULOPLASTY BAND (MODEL 607)KRH1996-08-27
57931285562439K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMDTY1996-01-16
57931006829122K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETDWF1996-03-26
57932040082943K953564MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVEDTL1996-02-02
57931184789281K953118CARACELLCAC1996-02-23
57931579200306K952532AFFINITY ARTERIAL BLOOD FILTERDTM1995-10-06
57931744766146K951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITJXG1995-09-18
57931089730973K950754MACRO SUCTION TUBE MODEL NO 10061GCY1995-04-25
57932029986886K933586MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACEDTZ1994-02-07
57931848590009K932252AFFINITY HOLLOW FIBER OXYGENATORDTZ1993-11-19
57931792421614K930154EL2-SERIES BLOOD COLLECTION REERVOIRDTN1993-07-01
57931233480495K926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIRDTN1993-02-19
57932063724837K926226INTERSEPT FILTERED CARDIOTOMY RESERVOIRDTZ1993-06-22
57931298635699K924643MEDTRONIC BIO-MEDICUS CANNULA INSERTION KITDWF1992-12-08
57931577251745K924642MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCERDWF1993-03-26
57931780692306K924529SIGNATURE(TM) CUSTOM TUBING PACKDWF1993-06-23
57931372039785K924208BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)DPT1993-07-08
57931355832014K920774MVR COLLAPSIBLE VENOUS RESERVOIR BAGDTN1992-10-19
57932017364315K915268CATHETER TWO STAGE VENOUS RETURNDWF1992-07-27
57931964649870K911790MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAGDTN1991-08-12
57931265657613K911789MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILTDTP1991-08-20
57931817082413K910421SATURATION/HEMATOCRIT MONITOR SYSTEMDRY1991-10-15
57931767293924K903632INTERSEPT 1375 VENOUS RESERVOIRDTN1990-12-17
57931366715303K901074CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULADWF1990-07-06
57931371093996K900994ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.DTL1990-08-15
57931792400220K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEDTZ1989-05-31
57931070939868K890707PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIALDWS1989-04-10
57931825612749K884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SETDQY1988-12-21
57931769442219K883956BIO-MEDICUS TUBING CONNECTORSDTL1988-10-28
57931870401575K883086INTERSEPT*PREBYPASS FILTERKRJ1988-09-16
57931466988851K882720SCIMED R30 SILICONE ASSIST RESERVOIRDTN1988-09-16
57931346743596K882136INTERSEPT* OXYGEN GAS LINE FILTERKRD1988-08-11
57931575377551K880671MODIFIED INTERSEPT PEDIATRIC BLOOD FILTERDTM1988-05-06
57931933898522K875353PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KITDWF1988-03-22
57931197277755K873561ELECTROMEDICS D1079EDTR1987-11-05
57931254037332K873423MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDERDTN1987-11-06
57931149064101K872033BIO-MEDICUS CANNULA-TUBINGDWF1987-12-07
57931148978549K865079ASPIRATING NEEDLE, CATALOG CODE #12006DWF1987-03-03
57931019887619K863476SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMODTZ1986-11-25
57931343366673K862303BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.JXG1986-08-12
57931790067583K860306BT-795/P AUTOMATED AUTOTRANSCAC1986-03-06
57931946844382K860149VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015DWF1986-03-31
57931709422085K854487VENOUS RETURN CANNULA W/CUFF 91039DWF1986-02-10
57931447227286K853586PRESSURE SENSING SYRINGE 65000DTL1985-11-14
57931703384269K852807BIO MEDICUS BIO PUMP MODEL BP-50KFM1985-09-30
57931850898112K852698BIO MEDICUS BIO PUMP MODEL BP-80KFM1985-09-30
57931485396561K852184ELECTRO-CAUTERY KNIFE CLEANER 6000 1HAM1985-06-04
57931658538014K850385INTRACARDIAC SUMP 12010DWF1985-04-29
57931674067141K845046PUL,MONARY ARTERY VENT CATHETERDWF1985-04-03
57931374451394K845045VENOUS RETURN CATHETER SS-1DWF1985-04-03
57931024554522K842375VENOUS CANNULA W/BENT, TIP WIREDWF1984-08-10
57931279658210K841482PRESSURE CATHETER PLACEMENT SET 50010DWF1984-06-11
57931119923243K840002ARTERIAL CANNULA CURVED BEVELED TIPDWF1984-02-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF1102025-06-20
DTZ312024-06-12
KRH312020-07-01
DQY212023-08-22
DTN182017-03-17
KFM172019-08-27
DTL142012-12-13
DTM132026-01-16
CAC112010-03-22
JXG102025-03-10
HRX102015-07-23
LOX92026-01-17
LIT92020-11-18
DTR82024-02-23
GWM72020-05-26
DPT72014-05-30
HCG52023-11-07
MIH52011-04-01
KRD42009-02-27
DWE41981-01-13
DRY32014-10-23
DRA32001-10-24
PCB22024-10-24
QHW22024-04-19
LWR22017-07-31
NPV22015-01-27
NPT22014-01-17
DRF22011-03-18
DTP22010-09-03
KRA22009-09-18
NDN22007-03-13
LPB22003-04-17
GCY21995-04-25
DWS21989-04-10
HAM21985-06-04
KPE21981-11-02
DTS21979-10-02
QJP12025-01-02
QJZ12024-09-12
NPV 12021-03-26