Product code NIK ยท Class 3
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
0510(k)s in 12 months (0 all time)
0recalls in 12 months (153 all time)
0recalls that name a 510(k)
Top companies in NIK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2017 | Boston Scientific Corporation VIGILANT X4 CRT-D, Model G247, Sterile.
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (O Terminated |
NIK | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia Terminated |
NIK | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmi Terminated |
NIK | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1
The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate progra Terminated |
NIK | None listed |
| Apr 12, 2017 | Medtronic Inc., Cardiac Rhythm and Heart Failure Amplia MRI Quad CRT-0 SureScan
Claria MRI Quad CRT-D SureScan
Compia MRI Quad CRT-D SureScan Terminated |
NIK | None listed |
| Dec 9, 2016 | Medtronic Inc., Cardiac Rhythm and Heart Failure Amplia MRI" CRT -D SureScan",
Amplia MRI" Quad CRT -D SureScan",
Claria MRI" CRT -D SureScan",
Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat epis Terminated |
NIK | None listed |
| Oct 21, 2016 | St Jude Medical Inc. Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q.
Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C.
Fortify and Fortify Assura implantable cardioverter defibrillator Terminated |
NIK | None listed |
| May 3, 2012 | St Jude Medical CRMD Cardiac Resynchronization Therapy (CRT) Leads
Trade Name: QuickFlex, QuickFlex XL
Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T
Intended use: Left Ventricular Cardiac Res Terminated |
NIK | None listed |
| May 3, 2012 | St Jude Medical CRMD Cardiac Resynchronization Therapy (CRT) Leads.
Trade Name: QuickSite, QuickSite XL
Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T
Intended use: Left Ventricular Cardiac Re Terminated |
NIK | None listed |
| Oct 21, 2010 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic Virtuoso II VR, model D274VRC, and model D294VRC not available in the U.S.. Digital Single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medt Terminated |
NIK | None listed |
| Oct 21, 2010 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic Virtuoso II DR, model D274DRG, and model D294DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. Medtro Terminated |
NIK | None listed |
| Oct 21, 2010 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneap Terminated |
NIK | None listed |
| Oct 21, 2010 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic Consulta CRT-D, model D224TRK and Model D234TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDDR). Sterilized using Terminated |
NIK | None listed |
| Oct 21, 2010 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized usi Terminated |
NIK | None listed |
| Sep 27, 2010 | ela Medical Llc Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770.
Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy Terminated |
NIK | None listed |
| May 8, 2010 | Boston Scientific CRM Corp CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac Resynchronization Therapy Defibrillator (CRT-D). These CRT-Ds provide ventricular tachyarrhythmia and cardiac Terminated |
NIK | None listed |
| Nov 9, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment This device is not approved in the United States.
Medtronic Concerto, C174AWK. Dual Chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular thera Terminated |
NIK | None listed |
| Nov 9, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Medtronic, Inc., Minneapolis, MN 55432 USA. Terminated |
NIK | None listed |
| Jan 28, 2009 | Medtronic Inc. Cardiac Rhythm Managment Maximo II CRT D284TRK, for ventricular pacing and defibrillation. Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and ter Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is desi Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia (VT Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Managemen Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF HE (model H239 ) cardiac resynchronization therapy defibrillator (CRT-D). Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D). Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp These models are not available in the US. CONTAK RENEWAL 4 (model H190, H195). CONTAK RENEWAL 4 HE (model H197, H199) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 410 Terminated |
NIK | None listed |
| Jul 11, 2007 | Boston Scientific CRM Corp CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5 Terminated |
NIK | None listed |
| Jul 27, 2006 | Boston Scientific CRM Corp These models are not available in the US.
Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. P Terminated |
NIK | None listed |
| Jul 27, 2006 | Boston Scientific CRM Corp Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, Terminated |
NIK | None listed |
| Jul 4, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization T Terminated |
NIK | None listed |
| May 23, 2006 | Guidant Corporation CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 H Terminated |
NIK | None listed |
| May 23, 2006 | Guidant Corporation CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4 Terminated |
NIK | None listed |
| May 16, 2006 | Guidant Corporation CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defib Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This I Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardi Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, Terminated |
NIK | None listed |
| May 2, 2006 | Guidant Corporation Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue Nort Terminated |
NIK | None listed |
| Nov 16, 2005 | St Jude Medical Photo Micro VR/DR Models V-232 Terminated |
NIK | None listed |
| Aug 3, 2005 | Guidant Corporation CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, Terminated |
NIK | None listed |
| Jul 19, 2005 | St Jude Medical Implantable Cardioverter Defibrilators
Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350)
Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide. Guidant corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac Resynchronization Therapy Defibrillator. Sterile EO. Guidant Corporation, 4100 Hamiline Avenue No Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene ox Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155) and CONTAK RENEWAL 3 AVT HE CRT-D(model no. M157 and M159) Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Gu Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Terminated |
NIK | None listed |
| Jun 30, 2005 | Guidant Corporation CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 41 Terminated |
NIK | None listed |
| Apr 13, 2005 | St Jude Medical Implantable Cardioverter-Defibrillator
Models affected include the following:
Atlas+ Models V-193, V-193C and V-243
Epic+ Models V-196, V-236 and V-239
Epic Models V-197 and V-233
Atlas Model V-242
Terminated |
NIK | 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 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.