FDA 510(k) Applications Submitted by MEDTRONIC INC.

FDA 510(k) Number Submission Date Device Name Applicant
K230640 03/08/2023 Affinity FusionÖ Oxygenator System Medtronic Inc.
K111339 05/12/2011 HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) MEDTRONIC INC.
K113235 11/02/2011 PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS MEDTRONIC INC.
K223168 10/11/2022 Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with BalanceÖ Biosurface Medtronic Inc.
K120808 03/16/2012 EXPORT XT CATHETER, EXPORT AP CATHETER MEDTRONIC INC.
K103386 11/18/2010 MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS MEDTRONIC INC.
K101212 04/30/2010 MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R MEDTRONIC INC.
K073324 11/27/2007 MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R MEDTRONIC INC.
K082670 09/15/2008 MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET MEDTRONIC INC.
K090659 03/12/2009 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY MEDTRONIC INC.
K101885 07/06/2010 MEDTRONIC C315 DELIVERY CATHETER MEDTRONIC INC.
K100274 01/29/2010 MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L MEDTRONIC INC.
K093535 11/16/2009 AUTOLOG AUTOTRANSFUSION SYSTEM MEDTRONIC INC.
K081804 06/26/2008 PIONEER PLUS CATHETER MEDTRONIC INC.
K072155 08/03/2007 PIONEER CATHETER MEDTRONIC INC.
K132030 07/01/2013 MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING MEDTRONIC INC.
K132995 09/24/2013 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO MEDTRONIC INC.
K123762 12/07/2012 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF MEDTRONIC INC.
K100470 02/18/2010 GTX 12 GIDEWIRE MEDTRONIC INC.
K130536 03/01/2013 EXPORT ADVANCE ASPIRATION CATHETER MEDTRONIC INC.
K101339 05/12/2010 ARCHER SUPER STIFF GUIDEWIRES MEDTRONIC INC.
K073523 12/14/2007 INTERCEPTOR PLUS CORONARY FILTER SYSTEMS MEDTRONIC INC.
K060400 02/15/2006 CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT MEDTRONIC INC.
K081082 04/16/2008 U-CLIP UNI-FIRE, MODEL M65 MEDTRONIC INC.
K200074 01/14/2020 O-arm O2 Imaging System Medtronic Inc.
K173664 11/29/2017 Medtronic O-arm O2 Imaging System Medtronic Inc.
K082475 08/28/2008 REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 MEDTRONIC INC.
K150614 03/10/2015 Reveal LINQ MEDTRONIC INC.
K120987 04/02/2012 DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF MEDTRONIC INC.
K132649 08/26/2013 REVEAL LINQ INSERTABLE CARDIAC MONITOR MEDTRONIC INC.
K132673 08/27/2013 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER MEDTRONIC INC.
K103464 11/24/2010 PACIFIC XTREME PTCA BALLOON DILATATION CATHETER MEDTRONIC INC.
K162892 10/17/2016 Achieve Advance Mapping Catheter MEDTRONIC INC.
K180456 02/20/2018 Bio-Medicus Adult Cannulae Kit Medtronic Inc.
K120988 04/02/2012 DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT MEDTRONIC INC.
K122811 09/13/2012 CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE MEDTRONIC INC.
K070886 03/30/2007 MEROGEL INJECTABLE BIORESORBABLE STENT MEDTRONIC INC.
K082464 08/27/2008 PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 MEDTRONIC INC.
K102953 10/04/2010 HEPARIN DOSE RESPONSE CARTRIDGE MEDTRONIC INC.
K093650 11/25/2009 BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM MEDTRONIC INC.
K100646 03/05/2010 AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE MEDTRONIC INC.
K101271 05/06/2010 HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX MEDTRONIC INC.
K103313 11/10/2010 HEPARIN ASSAY CONTROLS MEDTRONIC INC.
K103314 11/10/2010 CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL MEDTRONIC INC.
K153598 12/16/2015 Medtronic Bio-Medicus Adult Cannula Kit MEDTRONIC INC.
K100645 03/05/2010 AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE MEDTRONIC INC.
K111972 07/11/2011 AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF MEDTRONIC INC.
K132730 09/03/2013 BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE MEDTRONIC INC.
K141090 04/28/2014 NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER MEDTRONIC INC.
K143480 12/08/2014 Euphora Rapid Exchange Balloon Dilatation Catheter MEDTRONIC INC.
K201057 04/21/2020 Bio-Medicus Life Support Catheter and Introducer Medtronic Inc.
K201100 04/24/2020 Bio-Medicus Life Support Catheter and Introducer Medtronic Inc.
K122760 09/10/2012 AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE MEDTRONIC INC.
K122914 09/21/2012 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE MEDTRONIC INC.
K123448 11/08/2012 AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE MEDTRONIC INC.
K072990 10/24/2007 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID MEDTRONIC INC.
K121878 06/28/2012 CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES MEDTRONIC INC.
K123733 12/05/2012 CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM MEDTRONIC INC.
K120612 02/29/2012 MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT MEDTRONIC INC.
K141951 07/18/2014 DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE MEDTRONIC INC.
K113845 12/28/2011 TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE MEDTRONIC INC.
K111658 06/14/2011 AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC INC.
K131964 06/27/2013 BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE MEDTRONIC INC.
K132712 08/29/2013 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER MEDTRONIC INC.
K080428 02/19/2008 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY MEDTRONIC INC.
K121451 05/16/2012 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE MEDTRONIC INC.
K093828 12/14/2009 KYPH X HV-R BONE CEMENT MEDTRONIC INC.
K121767 06/15/2012 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE MEDTRONIC INC.
K122827 09/14/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 MEDTRONIC INC.
K122913 09/21/2012 AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 MEDTRONIC INC.
K093203 10/13/2009 CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 MEDTRONIC INC.
K123314 10/25/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE MEDTRONIC INC.
K132008 07/01/2013 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP MEDTRONIC INC.
K071641 06/15/2007 REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) MEDTRONIC INC.
K071655 06/18/2007 REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 MEDTRONIC INC.
K121265 04/26/2012 AMPHIRION PLUS PTA CATHETER MEDTRONIC INC.
K140695 03/19/2014 COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE MEDTRONIC INC.
K163032 10/31/2016 Kyphon Xpede Bone Cement Medtronic Inc.
K062041 07/19/2006 MODEL 3875 1 X 8 SC TEST STIMULATION LEAD MEDTRONIC INC.
K080509 02/25/2008 CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE MEDTRONIC INC.
K133903 12/20/2013 BIO-PROBE TRANSDUCER (ADULT) MEDTRONIC INC.
K223508 11/22/2022 Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device Medtronic Inc.
K151000 04/15/2015 O-Arm O2 Imaging System MEDTRONIC INC.
K141704 06/24/2014 NOVASHIELD INJECTABLE NASAL PACKING AND STENT MEDTRONIC INC.
K183353 12/03/2018 Telescope Guide Extension Catheter Medtronic Inc.
K183493 12/17/2018 SelectSite C304-HIS Deflectable Catheter System Medtronic Inc.
K100631 03/05/2010 AFFIITY CP CENTRIFUGAL BLOOD PUMP MEDTRONIC INC.
K121290 04/30/2012 AQUAMANTRYS3 BSC 9.1S MEDTRONIC INC.
K120537 02/22/2012 AQUAMANTYS3 9.5 XL BIPOLAR SEALER MEDTRONIC INC.
K101139 04/22/2010 PROSTIVA RF THERAPY MODEL 8929 HAND PIECE MEDTRONIC INC.
K113380 11/16/2011 PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR MEDTRONIC INC.
K102523 09/02/2010 MULTI-LEAD TRIALING CABLE MODEL 355531 MEDTRONIC INC.
K121219 04/23/2012 ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER MEDTRONIC INC.
K103764 12/23/2010 REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 MEDTRONIC INC.


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