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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

Matched from indexed company URL: Terumo Cardiovascular Systems Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11248413000204839TERUMO CARDIOVASCULAR SYSTEMS CORPORATION1Y2026-01-01125 BLUE BALL RD ELKTON MD US 21921
18281001828100TERUMO CARDIOVASCULAR SYSTEMS CORPORATION1N2026-01-016200 Jackson Road ANN ARBOR MI US 48103
30052288723005228872TERUMO CARDIOVASCULAR SYSTEMS THI PLANT1N2026-01-016190 JACKSON ROAD Ann Arbor MI US 48103
12121221000149028TERUMO CARDIOVASCULAR SYSTEMS CORPORATION1N2020-04-2528 Howe St ASHLAND MA US 01721

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
39951020133362K993772X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIRDTZ2000-06-05
39951592440478K9729623M CDI BLOOD PARAMETER MONITORING SYSTEM 500DRY1997-11-06
39951638551855K961000CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIRDTZ1996-10-02
1363621190534002K960916SAMS 8000 CARDIOPLEGIA MONITORDSJ1996-06-04
1363621784110343K953904SARNS 9000 UNIVERSAL ROLLER PUMPDWB1996-04-19
1363621684708248K953901SARNS 800 ROLLER PUMPDWB1996-04-19
1363621074749498K9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEMDWA1995-11-17
1363621841199121K940651SARNS ULTRASONIC AIR SENSORKRL1994-05-24
1363621512313268K935391SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACKGFA1994-02-24
39951304262079K923982OLYMPUS OES LAPAROSCOPY SYSTEMGCJ1993-03-15
39951209334972K922992CONDUCER CARDIOPLEGIA SET SITH MP4DWF1992-09-18
39951952549695K915363SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)KFM1993-07-28
39951412237249K915265CDI(TM) H/S CUVETTE, MODIFICATIONDRY1992-01-15
1363622070393591K915183SARNS 8000 MODULAR PERFUSION SYSTEMDTQ1992-07-08
1363621294056715K905686SARNS TEMPERATURE PROBE AND CONNECTORDWE1991-02-25
1363621872795141K902654CDI (TM) SYSTEM 100 MONITORING SYSTEMDTY1990-11-05
1363621338225006K902198SARNS DELPHIN BASE ADAPTER WITH BATTERYKFM1990-07-13
1363621474595259K900815SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVELDTW1990-05-09
39951312259685K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDUDTR1990-04-20
39952056644843K897039SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)DTR1990-03-16
1363621306132950K883603SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)DWC1988-11-03
1363621257512415K882758CENTRIFUGAL PUMP SYSTEM LX/DX VERSIONKFM1988-10-13
1363621381061950K871131SARNS 9000 HEART-LUNG CONSOLEDTQ1987-05-21
1363621965117643K841402TEMPERATURE CONTROL & MONITORDWC1984-06-11
39951629624892K823451CLEAR CARDIOPLEJIA DELIVERY SYSTEMDTR1983-01-14
1363621841101347K820638PEDIATRIC SUCKERKDC1982-04-09
39951829944899K820297WM. HARVEY OVERPRESSURE SAFETY VALVEDTL1982-03-12
1363621544180820K810416SARNS MINI-SUCKERGCY1981-03-05
39951870134000K810079SARNS INTEGRATED CARDIOPLEGIA DELIV. SYSKRI1981-01-30
743071906486859K250684OPUSWAVE Dual Sensor Imaging SystemNQQ2025-07-02
1363621230032799K234065CDI OneView Monitoring SystemDRY2024-04-25
1363621158301107K221895Terumo Advanced Perfusion System 1DTQ2023-04-18
39951805100120K200091Capiox iCP Centrifugal PumpKFM2021-11-18
39951338172621K182110CDI Blood Parameter Monitoring System 550DRY2018-11-02
1363621941390311K182110CDI Blood Parameter Monitoring System 550DRY2018-11-02
39952001039407K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)DTZ2018-06-22
1363621095266062K172220Advanced Perfusion System 1DTQ2017-08-17
1363621362063146K163531Advanced Perfusion System 1DTQ2017-06-07
1363621744993044K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1DWB2016-11-17
39951714705543K160206VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI2016-04-21
1363621612352670K153376Advanced Perfusion System 1DTQ2015-12-16
39951935609913K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell ReservoirDTZ2015-12-03
39951239116480K153143Capiox Advance Hardshell ReservoirDTN2015-12-02
39951391907267K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with XcoatingDTZ2015-12-02
39951412528205K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and ReservoirDTZ2015-11-19
39951622334787K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell ReservoirDTZ2015-10-20
1363621173982012K151349Advanced Perfusion System 1DTQ2015-08-27
39941964670830K150542Terumo Pump TubingDWE2015-05-01
39941788214049K150536Terumo Circuit TubingDWF2015-05-05
39941072569086K142500One Way Soft ValveMJJ2015-01-29
39951854153068K140774TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2014-06-02
39951738848897K140008VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEMGEI2014-10-31
1363621243633073K133658CDI BLOOD PARAMETER MONITORING SYSTEM 500DRY2014-07-25
1363621862080373K131618LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTDWB2013-09-27
1363621621307401K131041ADVANCED PERFUSION SYSTEM 1DTQ2014-02-20
39951140554321K130359CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHADTZ2013-03-13
39951260720974K130333CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIRDTZ2013-03-13
1363621676522615K123039CDI BLOOD PARAMETER MONITORING SYSTEM 500DRY2012-11-20
39951857958365K121209TERUMO PALL AL20X ARTERIAL FILTERDTM2012-05-08
39951465313522K112229SARN CENTRIFUGAL PUMPKFM2011-12-09
39951659011379K093992TERUMO LAUER LOCK ADAPTERDTL2010-05-19
39951690165417K092789VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEMGCJ2010-05-12
39951943325462K092644TERUMO PRESSURE ISOLATORDRS2009-12-10
39952065831159K083834TERUMO PALL AL6X ARTERIAL FILTERDTM2009-04-17
39951308479064K083747TERUMO PALL AL3X ARTERIAL FILTERDTM2009-08-20
39951179343066K083194VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550GCJ2009-01-16
39951940218991K082321TERUMO ROCSAFE HYBRID PERFUSION SYSTEMKFM2009-02-13
39951207855241K073474CAPIOX CIRCUIT CONNECTORSDTL2008-03-05
1363621014497193K071521TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEMDWC2007-11-21
39951736905971K070839MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIRDTN2007-04-24
39951378057658K062381CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIRDTZ2006-08-24
39951195656966K040023CAPIOX FLEXIBLE VENOUS RESERVOIRDTN2004-03-01
39951695347398K032128TERUMO AL8X ARTERIAL FILTER WITH X-COATINGDTM2003-08-01
39951093432599K031891VIRTUOSAPHGCJ2003-07-29
39951165191696K030505CAPIOX CARDIOTOMY RESERVOIRDPW2003-05-14
39951357681995K023056CIRCUIT TUBINGS WITH X-COATINGDWF2002-11-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTZ202018-06-22
DTQ162023-04-18
DRY122024-04-25
KFM112021-11-18
DWB82016-11-17
DTN62015-12-02
DTM62012-05-08
DTL62010-05-19
GCJ62010-05-12
DWF52015-05-05
DWC52007-11-21
GEI42016-04-21
DWE32015-05-01
DTR31990-04-20
DPW22003-05-14
DSJ21996-06-04
DWA21995-11-17
KRL21994-05-24
GFA21994-02-24
DTY21990-11-05
KRI21981-01-30
NQQ12025-07-02
MJJ12015-01-29
DRS12009-12-10
DTW11990-05-09
KDC11982-04-09
GCY11981-03-05

PMN#

73 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next