Company
Medtronic Inc. Cardiac Rhythm Managment
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
34recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 15 |
| DXY | Implantable Pacemaker Pulse-Generator | 6 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 5 |
| DPS | Electrocardiograph | 2 |
| DQY | Catheter, Percutaneous | 2 |
| NVZ | Pulse Generator, Permanent, Implantable | 2 |
| DTA | Tester, Pacemaker Electrode Function | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2009 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
This devic Terminated |
LWS | None listed |
| Aug 18, 2009 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 US Terminated |
LWS | None listed |
| Apr 8, 2009 | Medtronic Inc. Cardiac Rhythm Managment Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators. Terminated |
LWS | None listed |
| Jan 28, 2009 | Medtronic Inc. Cardiac Rhythm Managment Maximo II CRT D284TRK, for ventricular pacing and defibrillation. Terminated |
NIK | None listed |
| Jan 28, 2009 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation. Terminated |
LWS | None listed |
| Jan 28, 2009 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation. Terminated |
LWS | None listed |
| Sep 30, 2008 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Mi Terminated |
DQY | K021589 |
| Sep 30, 2008 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Attain LDS 6216A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minnea Terminated |
DQY | K021587 |
| Sep 30, 2008 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Med Terminated |
DTL | K052459 |
| Nov 6, 2007 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intende Terminated |
DPS | K024278 |
| Oct 25, 2007 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is d Terminated |
LWS | None listed |
| Oct 25, 2007 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead Terminated |
LWS | None listed |
| Oct 25, 2007 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, ca Terminated |
LWS | None listed |
| Oct 25, 2007 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing Terminated |
LWS | None listed |
| Jul 7, 2007 | Medtronic Inc. Cardiac Rhythm Managment Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventric Terminated |
NVZ | None listed |
| Jul 7, 2007 | Medtronic Inc. Cardiac Rhythm Managment Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing u Terminated |
NVZ | None listed |
| May 31, 2006 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-l Terminated |
DPS | K024278 |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only. Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, SSR303, SSR306 Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303 Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303. Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306 Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 Terminated |
DXY | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devic Terminated |
NIK | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devi Terminated |
NIK | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic InSync III Marquis, model 7279 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devi Terminated |
NIK | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventr Terminated |
LWS | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, Terminated |
NIK | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Marquis DR, model 7274 Dual Chamber Implantable Cardioverter Defibrillator (ICD) devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventr Terminated |
LWS | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Maximo VR, model 7232 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventr Terminated |
LWS | None listed |
| Mar 11, 2005 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of vent Terminated |
LWS | None listed |
| Nov 17, 2004 | Medtronic Inc. Cardiac Rhythm Managment Medtronic CapSureFix Novus Lead Model 5076. Terminated |
DTA | None listed |
| Jul 20, 2004 | Medtronic Inc. Cardiac Rhythm Managment Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271 Terminated |
LWS | None listed |
| Jul 20, 2004 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx Terminated |
LWS | None listed |