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. |
| K240693 |
03/13/2024 |
LINQ IIÖ Insertable Cardiac Monitor (ICM) |
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. |
| K233320 |
09/29/2023 |
LINQ IIÖ Insertable Cardiac Monitor (LNQ22) |
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. |
| K241259 |
05/06/2024 |
Amplatz Goose Neck Snare Kit |
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. |
| K233397 |
10/03/2023 |
Cosine-10TM Diagnostic Catheter |
Medtronic, Inc. |
| K230553 |
02/28/2023 |
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application |
Medtronic, Inc. |
| K233562 |
11/06/2023 |
LINQ II Insertable Cardiac Monitor |
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. |
| K241828 |
06/24/2024 |
Affera Integrated Mapping System; Impedance Localization Patch Kit |
Medtronic, Inc. |
| K152054 |
07/23/2015 |
Confida Adaptive Sheath |
Medtronic, Inc. |
| K243435 |
11/05/2024 |
Magnetic Localization Patch Kit (AFR-00021) |
Medtronic, Inc. |
| K233943 |
12/14/2023 |
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) |
Medtronic, Inc. |
| K243892 |
12/18/2024 |
Affera Integrated Mapping System |
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. |
| K250558 |
02/25/2025 |
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) |
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. |
| K231206 |
04/27/2023 |
DLP 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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