FDA 510(k) Applications Submitted by MEDTRONIC VASCULAR

FDA 510(k) Number Submission Date Device Name Applicant
K982220 06/24/1998 MODEL 2872 BIPOLAR LEAD ADAPTOR KIT MEDTRONIC VASCULAR
K043080 11/08/2004 HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR MEDTRONIC VASCULAR
K011395 05/07/2001 MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B MEDTRONIC VASCULAR
K232190 07/24/2023 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter Medtronic Vascular
K091582 06/02/2009 GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 MEDTRONIC VASCULAR
K162027 07/22/2016 TRAcelet Compression Device MEDTRONIC VASCULAR
K192296 08/23/2019 Medtronic 6F Taiga Guiding Catheter Medtronic Vascular
K062057 07/20/2006 U-CLIP DEVICE, MODEL NC65 MEDTRONIC VASCULAR
K053252 11/21/2005 U-CLIP DEVICE, MODELS B140, B160 AND B180 MEDTRONIC VASCULAR
K043291 11/29/2004 CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 MEDTRONIC VASCULAR
K971756 05/12/1997 MEDTRONIC MODEL 3998 LEAD MEDTRONIC VASCULAR
K011584 05/23/2001 MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF MEDTRONIC VASCULAR
K972043 06/02/1997 MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER MEDTRONIC VASCULAR
K972906 08/06/1997 MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) MEDTRONIC VASCULAR
K953742 08/08/1995 BIFURCATED Y-EXTENSION MEDTRONIC VASCULAR
K982902 08/14/1998 PERIPHERAL NERVE STIMULATION MEDTRONIC VASCULAR
K964172 10/18/1996 MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL MEDTRONIC VASCULAR
K031518 05/15/2003 EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, MEDTRONIC VASCULAR
K042070 08/02/2004 HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 MEDTRONIC VASCULAR
K042175 08/11/2004 HEPARINASE HR ACT CONTROL, MODEL 550-12 MEDTRONIC VASCULAR
K042206 08/16/2004 PURPLE/BLACK HEPARIN ASSAY CONTROL MEDTRONIC VASCULAR
K070311 02/01/2007 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 MEDTRONIC VASCULAR
K032138 07/11/2003 MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER MEDTRONIC VASCULAR
K000430 02/09/2000 AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 MEDTRONIC VASCULAR
K961836 05/13/1996 MAXIMA FORTE HARDSHELL VENOUS RESERVOIR MEDTRONIC VASCULAR
K962641 07/05/1996 MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER MEDTRONIC VASCULAR
K992910 08/30/1999 AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) MEDTRONIC VASCULAR
K973475 09/12/1997 CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) MEDTRONIC VASCULAR
K955291 11/16/1995 DUALSCREEN MEDTRONIC VASCULAR
K123358 10/31/2012 PACIFIC PLUS MEDTRONIC VASCULAR
K133539 11/18/2013 TOTAL ACROSS MEDTRONIC VASCULAR
K040568 03/04/2004 POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS MEDTRONIC VASCULAR
K040812 03/29/2004 DETECT SURGICAL PACING AND MAPPING TOOL MEDTRONIC VASCULAR
K030201 01/21/2003 MODIFICATION TO EXPORT ASPIRATION CATHETER MEDTRONIC VASCULAR
K050139 01/21/2005 MODIFICATION TO: EXPORT CATHETER MEDTRONIC VASCULAR
K010579 02/27/2001 STENT SUPPORT GUIDE CATHETER MEDTRONIC VASCULAR
K000677 02/29/2000 ZUMA GUIDE CATHETERS MEDTRONIC VASCULAR
K030671 03/03/2003 MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB MEDTRONIC VASCULAR
K030779 03/11/2003 5F MEDTRONIC LAUNCHER GUIDE CATHETER MEDTRONIC VASCULAR
K040869 04/02/2004 EXPORT CATHETER MEDTRONIC VASCULAR
K021256 04/19/2002 Z3 GUIDE CATHETER MEDTRONIC VASCULAR
K001969 06/28/2000 GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 MEDTRONIC VASCULAR
K992237 07/02/1999 MEDTRONIC GT2 FUSION GUIDE WIRES MEDTRONIC VASCULAR
K051846 07/07/2005 7F SHERPA NX GUIDE CATHETER MEDTRONIC VASCULAR
K022764 08/21/2002 7F LAUNCHER GUIDE CATHETER MEDTRONIC VASCULAR
K042489 09/14/2004 6F Z4 GUIDE CATHETER MEDTRONIC VASCULAR
K023303 10/03/2002 EXPORT ASPIRATION CATHETER MEDTRONIC VASCULAR
K023402 10/10/2002 8F LAUNCHER GUIDE CATHETER MEDTRONIC VASCULAR
K023878 11/21/2002 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM MEDTRONIC VASCULAR
K991066 03/31/1999 MADTRONIC DLP ARTERIAL CANNULAE MEDTRONIC VASCULAR
K960631 02/14/1996 MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX MEDTRONIC VASCULAR
K062264 08/04/2006 COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM MEDTRONIC VASCULAR
K071253 05/04/2007 AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 MEDTRONIC VASCULAR
K041244 05/11/2004 POLYGRAM NET BIOFEEDBACK APPLICATION MEDTRONIC VASCULAR
K021804 06/03/2002 PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM MEDTRONIC VASCULAR
K052413 09/02/2005 TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 MEDTRONIC VASCULAR
K984435 12/11/1998 MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M MEDTRONIC VASCULAR
K010906 03/26/2001 MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 MEDTRONIC VASCULAR
K003535 11/16/2000 STYLET KIT, MODELS 6254,6282,6293 MEDTRONIC VASCULAR
K984271 11/30/1998 MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 MEDTRONIC VASCULAR
K021589 05/15/2002 ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 MEDTRONIC VASCULAR
K021587 05/15/2002 ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A MEDTRONIC VASCULAR
K012083 07/03/2001 ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 MEDTRONIC VASCULAR
K012130 07/09/2001 ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM MEDTRONIC VASCULAR
K012225 07/16/2001 ATTAIN 6215 VENOGRAM BALLOON CATHETER MEDTRONIC VASCULAR
K024278 12/23/2002 PACEART SYSTEM MEDTRONIC VASCULAR
K061958 07/11/2006 MEDTRONIC EXPORT XT CATHETER MEDTRONIC VASCULAR
K000445 02/10/2000 MEDTRONIC MODEL 7499 EXTENSION MEDTRONIC VASCULAR
K123990 12/26/2012 SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING MEDTRONIC VASCULAR
K953118 07/03/1995 CARACELL MEDTRONIC VASCULAR
K032312 07/28/2003 ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM MEDTRONIC VASCULAR
K013517 10/22/2001 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 MEDTRONIC VASCULAR
K032926 09/22/2003 EKG SPEAKS MEDTRONIC VASCULAR
K033540 11/10/2003 TRANSXCHANGE SUPPORT CATHETER MEDTRONIC VASCULAR
K990104 01/12/1999 MEDTRONIC MODEL 7495 EXTENSION KIT MEDTRONIC VASCULAR
K971474 04/23/1997 MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL MEDTRONIC VASCULAR
K101777 06/25/2010 PIONEER PLUS CATHETER, MODEL PLUS 120 MEDTRONIC VASCULAR
K021902 06/10/2002 MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 MEDTRONIC VASCULAR
K032561 08/20/2003 RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR MEDTRONIC VASCULAR
K031211 04/17/2003 ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH MEDTRONIC VASCULAR
K042194 08/12/2004 ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY MEDTRONIC VASCULAR
K032622 08/26/2003 ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS MEDTRONIC VASCULAR
K024035 12/06/2002 ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY MEDTRONIC VASCULAR
K024032 12/06/2002 ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY MEDTRONIC VASCULAR
K033050 09/29/2003 EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 MEDTRONIC VASCULAR
K173515 11/14/2017 Admiral Xtreme Medtronic Vascular
K000379 02/07/2000 MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 MEDTRONIC VASCULAR
K001138 04/10/2000 AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 MEDTRONIC VASCULAR
K011864 06/14/2001 TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B MEDTRONIC VASCULAR
K012538 08/07/2001 TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE MEDTRONIC VASCULAR
K003724 12/04/2000 CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B MEDTRONIC VASCULAR
K060418 02/17/2006 8F SHERPA NX GUIDE CATHETER MEDTRONIC VASCULAR
K062420 08/18/2006 5F SHERPA ACTIVE NX GUIDE CATHETER MEDTRONIC VASCULAR
K013963 12/03/2001 MODEL 9210 DELIVERY CATHETER, MODEL 9210 MEDTRONIC VASCULAR
K022238 07/11/2002 MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 MEDTRONIC VASCULAR
K993677 11/01/1999 MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT MEDTRONIC VASCULAR
K000210 01/24/2000 MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT MEDTRONIC VASCULAR
K061416 05/22/2006 SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 MEDTRONIC VASCULAR
K052459 09/07/2005 6248VAL ADJUSTABLE VALVE MEDTRONIC VASCULAR
K000955 03/24/2000 PLACER MODEL 6232 STEERABLE STYLET MEDTRONIC VASCULAR
K220773 03/16/2022 Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Medtronic Vascular
K161287 05/09/2016 DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak MEDTRONIC VASCULAR
K162097 07/29/2016 InTRAkit Medtronic Vascular
K961679 05/01/1996 TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS MEDTRONIC VASCULAR
K961936 05/20/1996 MODEL 2188 CORONARY SINUS LEAD. MEDTRONIC VASCULAR
K972242 06/16/1997 REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM MEDTRONIC VASCULAR
K994331 12/23/1999 REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR MEDTRONIC VASCULAR
K000105 01/14/2000 MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), MEDTRONIC VASCULAR
K010300 02/01/2001 MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION MEDTRONIC VASCULAR
K965251 12/19/1996 MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM MEDTRONIC VASCULAR
K042190 08/12/2004 MODEL 6416 TEMPORARY PACING LEAD SYSTEM MEDTRONIC VASCULAR
K061127 04/24/2006 CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R MEDTRONIC VASCULAR
K034058 12/30/2003 SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 MEDTRONIC VASCULAR
K051386 05/27/2005 MASTERGRAFT PUTTY BONE VOID FILLER MEDTRONIC VASCULAR
K024069 12/10/2002 ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 MEDTRONIC VASCULAR
K062727 09/13/2006 CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE MEDTRONIC VASCULAR
K013392 10/15/2001 CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 MEDTRONIC VASCULAR
K070288 01/30/2007 CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 MEDTRONIC VASCULAR
K031247 04/18/2003 CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM MEDTRONIC VASCULAR
K041338 05/20/2004 MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES MEDTRONIC VASCULAR
K230156 01/19/2023 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter Medtronic Vascular
K011098 04/11/2001 REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR MEDTRONIC VASCULAR
K003667 11/28/2000 REVEAL PLUS INSERTABLE LOOP RECORDER MEDTRONIC VASCULAR
K973360 09/08/1997 MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD MEDTRONIC VASCULAR
K963898 09/27/1996 MODEL 6495 BIPOLAR TEMPORARY PACING LEAD MEDTRONIC VASCULAR
K081573 06/05/2008 MEDTRONIC EXPORT AP CATHETER MEDTRONIC VASCULAR
K082873 09/29/2008 MEDTRONIC ANGIOGRAPHIC GUIDE WIRES MEDTRONIC VASCULAR
K031274 04/22/2003 MODEL 5071 MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR
K012460 08/01/2001 MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR
K012452 08/01/2001 MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD MEDTRONIC VASCULAR
K012454 08/01/2001 MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MEDTRONIC VASCULAR
K012458 08/01/2001 MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD MEDTRONIC VASCULAR
K012459 08/01/2001 MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MEDTRONIC VASCULAR
K962036 05/24/1996 MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD MEDTRONIC VASCULAR
K960446 02/01/1996 MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES MEDTRONIC VASCULAR
K961520 04/22/1996 UNIPOLAR IPG GROUND CABLE, MODEL 5473 MEDTRONIC VASCULAR
K083422 11/19/2008 6F TAIGA GUIDING CATHETER MEDTRONIC VASCULAR


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