FDA.reportPublic FDA data

Medtronic Grand Rapids

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039553073003955307Medtronic Grand Rapids1N2026-01-01620 Watson SW Grand Rapids MI US 49504

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3232511413668846K973485CLEARVIEW BLOWER/MISTERFQH1997-12-08
3232511006829122K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETDWF1996-03-26
3232511089730973K950754MACRO SUCTION TUBE MODEL NO 10061GCY1995-04-25
3232511577251745K924642MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCERDWF1993-03-26
3232511780692306K924529SIGNATURE(TM) CUSTOM TUBING PACKDWF1993-06-23
3232511366715303K901074CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULADWF1990-07-06
3232511825612749K884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SETDQY1988-12-21
3232511933898522K875353PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KITDWF1988-03-22
3232511149064101K872033BIO-MEDICUS CANNULA-TUBINGDWF1987-12-07
3232511148978549K865079ASPIRATING NEEDLE, CATALOG CODE #12006DWF1987-03-03
3232511946844382K860149VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015DWF1986-03-31
3232511844773532K855144TOURIQUET KIT WITH SNAREGDJ1986-02-05
3232511485396561K852184ELECTRO-CAUTERY KNIFE CLEANER 6000 1HAM1985-06-04
3232511658538014K850385INTRACARDIAC SUMP 12010DWF1985-04-29
3232511374451394K845045VENOUS RETURN CATHETER SS-1DWF1985-04-03
3232511279658210K841482PRESSURE CATHETER PLACEMENT SET 50010DWF1984-06-11
3232511119923243K840002ARTERIAL CANNULA CURVED BEVELED TIPDWF1984-02-13
3232511130204206K840001ARTERIAL CANNULA STRAIGHT BEVELED TIPDWF1984-02-13
3232511900770799K834352ADULT VENT CATHETERDRA1984-01-27
3232511829274315K834039INFANT VENT CATHETER 12001 W/SIDE VENTDWF1984-01-03
3232511424861329K812852SET FOR ASEPTIC DECANTING OF A FLEX I.VKPE1981-11-02
3232511783177253K810820CARDIOPULMONARY BYPASSDWF1981-04-03
3232511935300786K810548CARDIOPULMINARY BYPASS CATHETER CANNULADWF1981-03-17
3232511201825067K790565AORTIC ROOT CANNULADWF1979-06-11
3232511097230047K253998Clearview Intracoronary ShuntsDWF2026-01-20
3232511553046710K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaDWF2025-06-20
3232511185961092K231206DLP Silicone Coronary Artery Ostial CannulaeDWF2023-12-07
3232511030700710K230960DLP™ Silicone Coronary Artery Ostial CannulaeDWF2023-05-04
3232511016171161K200514Cardioblate Gemini-s Surgical Ablation DeviceOCL2020-06-03
3232511585113157K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceOCL2019-05-30
3232511630152726K182586DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure PortDWF2018-10-19
3232511553450337K150422EOPA 3D Arterial CannulaDWF2015-03-20
3232511444918842K143107DLP Vein Graft CannulaDWF2015-01-07
3232511192307078K141951DLP SILICONE CORONARY ARTERY OSTIAL CANNULAEDWF2014-08-15
3232512035287235K140192CARPENTIER BI-CAVAL FEMORAL CANNULADWF2014-05-22
3232511242879922K140165MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VEDWF2014-05-20
3232511597046972K132995DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIODWF2013-10-31
3232511549257246K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTEROLO2013-08-14
3232511140153178K131269DLP CORONARY OSTIAL PERFUSION CANNULAEDWF2013-07-10
3232511691819794K123762DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFFDWF2013-03-27
3232512017362161K121451CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICEOCL2012-06-14
3232511150717212K120988DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHTDWF2012-07-25
3232511280405993K120612MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNTDWF2012-05-25
3232511401128619K113235PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSDXS2011-12-02
3232511956552537K100274MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014LDWF2010-05-10
3232511993215755K093203CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841GEI2010-02-26
3232511331912796K080509CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICEOCL2008-05-05
3232511629734142K070288CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814OCL2007-06-18
3232512062055006K052524BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KITDWF2005-11-22
3232511918054160K052372MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437CDWF2005-09-22
3232511214727318K043179SELECT 3D ARTERIAL CANNULADWF2005-02-08
3232511247437558K040173PEDIATRIC AORTIC ROOT CANNULADWF2004-03-19
3232511230333076K031037EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIREDWF2003-05-13
3232511195114693K030696RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)DWF2003-04-11
3232512035266548K024069ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106DWF2003-01-08
3232511004762166K022272MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)DWF2003-01-08
3232511184263727K001153MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORMHAW2000-05-03
3232511040203265
3232511216715252
3232511473859133
3232511519817779
3232511615354845

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF412026-01-20
OCL52020-06-03
OLO12013-08-14
DXS12011-12-02
GEI12010-02-26
HAW12000-05-03
FQH11997-12-08
GCY11995-04-25
DQY11988-12-21
GDJ11986-02-05
HAM11985-06-04
DRA11984-01-27
KPE11981-11-02