FDA 510(k) Applications Submitted by Medtronic, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K223488 11/21/2022 ClosureFastÖ Endovenous Radiofrequency Ablation Catheter Medtronic, Inc.
K190825 04/01/2019 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc.
K201011 04/17/2020 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc.
K211304 04/29/2021 LINQ II Insertable Cardiac Monitor Medtronic, Inc.
K180873 04/03/2018 Medtronic Model 53401 External Pulse Generator (EPG) Medtronic, Inc.
K181973 07/24/2018 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc.
K162550 09/13/2016 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc.
K150567 03/06/2015 MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT Medtronic, Inc.
K132645 08/23/2013 THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES MEDTRONIC, INC.
K150422 02/19/2015 EOPA 3D Arterial Cannula MEDTRONIC, INC.
K153160 11/02/2015 AVIVO Mobile Patient Management (MPM) System MEDTRONIC, INC.
K160091 01/15/2016 Temperature Probe, Affinity Temperature Probe Medtronic, Inc.
K191526 06/10/2019 Cardioblate CryoFlex Surgical Ablation System Medtronic, Inc.
K152335 08/19/2015 Export Advance Aspiration Catheter Medtronic, Inc.
K112917 10/03/2011 ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID MEDTRONIC, INC.
K140972 04/16/2014 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING MEDTRONIC, INC.
K210484 02/19/2021 LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System Medtronic, Inc.
K160809 03/24/2016 Reveal LINQ MEDTRONIC, INC.
K221962 07/05/2022 LINQ II Insertable Cardiac Monitor Medtronic, Inc.
K150117 01/20/2015 Medtronic Patient Asistant Medtronic, Inc.
K160689 03/11/2016 Reveal LINQ MEDTRONIC, INC.
K200795 03/26/2020 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit Medtronic, Inc.
K132924 09/18/2013 MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) MEDTRONIC, INC.
K170583 02/28/2017 Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface Medtronic, Inc.
K191444 05/31/2019 Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir Medtronic, Inc.
K162774 10/03/2016 MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) Medtronic, Inc.
K162958 10/24/2016 MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge Medtronic, Inc.
K153139 10/30/2015 Achieve ST Mapping Catheter, Catheter Connecting Cable MEDTRONIC, INC.
K190557 03/05/2019 Bio-Medicus Insertion Kit Medtronic, Inc.
K140165 01/22/2014 MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE MEDTRONIC, INC.
K140192 01/27/2014 CARPENTIER BI-CAVAL FEMORAL CANNULA MEDTRONIC, INC.
K151523 06/05/2015 Uncoated Tubing and Connector Components MEDTRONIC, INC.
K181918 07/18/2018 CardioInsight Cardiac Mapping System Medtronic, Inc.
K200630 03/10/2020 Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags Medtronic, Inc.
K201118 04/27/2020 Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level Medtronic, Inc.
K141233 05/13/2014 AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE MEDTRONIC, INC.
K133157 10/17/2013 TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 MEDTRONIC, INC.
K143073 10/27/2014 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface Medtronic, Inc.
K132972 09/23/2013 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE MEDTRONIC, INC.
K230553 02/28/2023 LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application Medtronic, Inc.
K223630 12/05/2022 Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System Medtronic, Inc.
K143107 10/29/2014 DLP Vein Graft Cannula MEDTRONIC, INC.
K131269 05/03/2013 DLP CORONARY OSTIAL PERFUSION CANNULAE MEDTRONIC, INC.
K163008 10/28/2016 CareLink SmartSync Device Manager - Pacing System Analyzer Medtronic, Inc.
K213631 11/17/2021 Chocolate PTA Balloon Catheter Medtronic, Inc.
K182586 09/20/2018 DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port Medtronic, Inc.
K201449 06/01/2020 SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring Medtronic, Inc.
K111657 06/14/2011 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE MEDTRONIC, INC.
K172626 09/01/2017 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiot Medtronic, Inc.
K172984 09/27/2017 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Medtronic, Inc.
K152054 07/23/2015 Confida Adaptive Sheath Medtronic, Inc.
K143316 11/19/2014 Attain Hybrid Guide Wire Medtronic, Inc.
K180030 01/03/2018 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc.
K180122 01/16/2018 TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) Medtronic, Inc.
K192389 09/03/2019 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc.
K192636 09/23/2019 TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) Medtronic, Inc.
K200456 02/25/2020 Becker External Drainage and Monitoring System Medtronic, Inc.
K132617 08/21/2013 MEDTRONIC INPUT PS INTRODUCER MEDTRONIC, INC.
K153038 10/19/2015 Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit MEDTRONIC, INC.
K151532 06/08/2015 KYPHON ELEMENT Inflatable Bone Tamp MEDTRONIC, INC.
K110693 03/11/2011 PACEART OPTIMA SYSTEM SOFTWARE MEDTRONIC, INC.
K171308 05/03/2017 Tubing Pack Medtronic, Inc.
K171979 06/30/2017 Tubing Pack Medtronic, Inc.
K162016 07/21/2016 Affinity NT Oxygenator with Cortiva BioActive Surface MEDTRONIC, INC.
K162896 10/17/2016 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface MEDTRONIC, INC.
K191029 04/18/2019 Affinity 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 Int Medtronic, Inc.
K201068 04/22/2020 Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface Medtronic, Inc.
K230960 04/05/2023 DLPÖ Silicone Coronary Artery Ostial Cannulae Medtronic, Inc.
K162054 07/25/2016 Medtronic Temporary External Pacemaker 53401 MEDTRONIC, INC.
K162855 10/12/2016 Reveal LINQ Medtronic, Inc.
K211057 04/09/2021 LigaPASS« Spinal System, CD HorizonÖ Spinal System Medtronic, Inc.


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