FDA.reportPublic FDA data

Viant Medical, Inc

Matched from indexed company URL: VIANT MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22440122244012Viant Medical, Inc1N2026-01-016 CENTURY RD. S Plainfield NJ US 07080
30049769653004976965Viant Medical, LLC1N2026-01-014545 Kroemer Rd Fort Wayne IN US 46818
30061946793006194679Viant Medical SUZHOU EPZ Co., Ltd1N2026-01-01288 SHENGPU ROAD, SUZHOU INDUSTRIAL PARK, SUZHOU JIANGSU PROVINCE CN 215021
30094938753009493875Viant Medical, Inc.1N2026-01-015079 33rd St SE Grand Rapids MI US 49512
14196291419629Viant Medical, Inc.1N2020-04-25620 WATSON SW GR MI US 49504

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2253901585052807P040033BIRMINGHAM HIP RESURFACING (BHR) SYSTEMNXT2006-05-09
2110091717268760K994208AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354DTM2000-01-13
2110091991249195K994171MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAEDWF2000-04-27
2110091417224420K973485CLEARVIEW BLOWER/MISTERFQH1997-12-08
2110091823859469K971105MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEMDTN1997-07-11
2110091683575870K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETDWF1996-03-26
2110091825353981K952532AFFINITY ARTERIAL BLOOD FILTERDTM1995-10-06
2110091290601418K936003AFFINITY CVRDTN1994-06-20
2110091116104567K933586MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACEDTZ1994-02-07
2110091882414749K926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIRDTN1993-02-19
2110091794392095K911789MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILTDTP1991-08-20
2110091069472816K884560SCIMED ECMOTHERM(TM) HEAT EXCHANGERDTR1989-04-03
2110091283206799K860149VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015DWF1986-03-31
2110091198478912K830573PRE VUEFOZ1983-03-29
2110091400698519K812292AUTOTRANS BT795CAC1981-10-23
2110091934232268K810548CARDIOPULMINARY BYPASS CATHETER CANNULADWF1981-03-17
2110091656581384K803277TYGON TUBINGDWE1981-01-13
2110091237397606K191444Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous ReservoirDTZ2019-09-27
2110091365045194K191077Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive MotorKFM2019-08-27
2110091538755796K191029Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® BiosurfacDTZ2019-05-17
2110091870933306K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceOCL2019-05-30
2110091212118732K183511Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)DTZ2019-03-18
2110092050771994K183490Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance BiosurfaceDTZ2019-04-12
2110091871108940K182928CD Horizon™ Spinal SystemNQP2019-01-11
2110091192297775K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation DeviceOCL2018-12-19
2110121307378988K181141OverStitch Endoscopic Suturing System and AccessoriesOCW2018-06-27
2110121390329037K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial AdaptorONB2018-08-17
2110121904287163K162129RENASYS-G Gauze Dressing Kits with Soft PortOMP2016-08-31
2110091877025428K153598Medtronic Bio-Medicus Adult Cannula KitDWF2016-01-15
2110091872929941K153240Styrker OrthoMap Express Knee SystemOLO2016-07-07
2110121626403920K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power SupplyOMP2016-08-04
2110091489947614K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port DeviceOMP2015-07-23
2110091384125013K143107DLP Vein Graft CannulaDWF2015-01-07
2110121002756864K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX CanistersOMP2015-04-29
2110091860664711K141951DLP SILICONE CORONARY ARTERY OSTIAL CANNULAEDWF2014-08-15
194911664941196K140908JUGGERKNOT MINI SOFT ANCHORDZL2014-10-02
2110091147826815K140165MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VEDWF2014-05-20
2110091213548327K133157TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6DRY2014-10-23
2110091170229347K132995DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIODWF2013-10-31
2110121634440198K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTEROLO2013-08-14
2110091559007832K131269DLP CORONARY OSTIAL PERFUSION CANNULAEDWF2013-07-10
2110091704181578K123762DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFFDWF2013-03-27
2110091458518942K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEDTM2013-03-19
2110121622358573K123187RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULADWF2013-02-22
2110091408073325K122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEDTM2012-12-07
2110091368389458K121451CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICEOCL2012-06-14
2253901508621787K120121COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATEPHX2012-02-16
194911208921381K103825V-GO INSULIN DELIVERY SYSTEMLZG2011-02-23
2110121474068848K1023143M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29
2110091902981440K100646AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACEDTM2010-12-16
2110091288246084K093535AUTOLOG AUTOTRANSFUSION SYSTEMCAC2010-03-22
2110091004505799K093203CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841GEI2010-02-26
2110121852661481K091315COVIDIEN EXTENDED TIP APPLICATORFMF2009-06-05
2110091057459745K090162EVICEL APPLICATION DEVICEFMF2009-02-20
2110121231480764K082454MICROMYST APPLICATOR, MODEL 20-5000FMF2008-11-07
2110091098959298K082425TANDEMHEART TRANSSEPTAL CANNULA- EF 72DWF2008-09-18
2253901243750957K080642COMPREHENSIVE REVERSE SHOULDERPHX2008-07-09
2110091346833697K080509CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICEOCL2008-05-05
2110091574542094K071253AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014DTM2007-07-03
2110091430475388K070288CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814OCL2007-06-18
2253901131180849K052906ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMPHX2005-12-19
2110091033886443K052570TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221DWF2006-01-17
2110091287207073K050109TRILLIUM BIOPUMP PLUS, MODEL BPX80TKFM2005-02-11
2110091562832262K021980HIP MODULE FOR THE STEALTHSTATION SYSTEMHAW2002-11-19
2110091665756393K021287TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TTDTN2002-05-07
2110091129189353K013084AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351TDTM2001-09-27
2110091224922137K012937KNEE MODULE FOR THE STEALTHSTATION SYSTEMHAW2002-01-25
2110091740114547K001138AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354DTM2000-04-27
2110091164217914BK140093
2110091146033325
2110121149675457
2110121233310186
2110121292633036
2253901357644662
2253901454684697
2253901750228208
194911907343780
2253901988566595
2253901015544151
2253901023585319
2253901028756360
2253901045513168
2253901047202514
2253901052164407
2253901072083753
2253901077950446
2253901078374755
2253901085233413
2253901095402675
2253901106783083
2253901110909058
2253901113602226
2253901131180849
2253901135296199
2253901143242709
2253901143822148
2253901144301866
2253901146033325
2253901148214814
2253901150970468
2110121194350323
2253901195245118
2253901206525443
2253901207971169
2253901209401630
2253901219853103
2253901226505129
2110121231480764
2253901262702041
2110121291639312
2253901299277677
2253901307968803
2253901319633669
2253901326761093
2253901327048212
2110121334431510

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF142016-01-15
DTM82013-03-19
DTZ52019-09-27
OCL52019-05-30
OMP42016-08-31
DTN42002-05-07
PHX32012-02-16
FMF32009-06-05
KFM22019-08-27
OLO22016-07-07
CAC22010-03-22
HAW22002-11-19
NQP12019-01-11
ONB12018-08-17
OCW12018-06-27
DRY12014-10-23
DZL12014-10-02
LZG12011-02-23
OOI12010-10-29
GEI12010-02-26
NXT12006-05-09
FQH11997-12-08
DTP11991-08-20
DTR11989-04-03
FOZ11983-03-29
DWE11981-01-13

GUDID#

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