FDA.reportPublic FDA data

Viant Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
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
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
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
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
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
2110121076671088
2110121194350323
2110121231480764
2110121291639312
2110121334431510
2110121377908891
2110121486001707
2110121622358573
2110121631667855
2110121719910639
2110121801150406
2110121842113411
2110121852661481
2110121872929941

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
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
OOI12010-10-29
GEI12010-02-26
FQH11997-12-08
DTP11991-08-20
DTR11989-04-03
FOZ11983-03-29
DWE11981-01-13