ClearanceBrief
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)
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Top companies in NIK

DateFirm and productCodeLinked 510(k)
Oct 4, 2017Boston 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
NIKNone listed
Sep 28, 2017Sorin 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
NIKNone listed
Sep 28, 2017Sorin 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
NIKNone listed
Aug 28, 2017St 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
NIKNone listed
Apr 12, 2017Medtronic 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
NIKNone listed
Dec 9, 2016Medtronic 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
NIKNone listed
Oct 21, 2016St 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
NIKNone listed
May 3, 2012St 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
NIKNone listed
May 3, 2012St 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
NIKNone listed
Oct 21, 2010Medtronic 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
NIKNone listed
Oct 21, 2010Medtronic 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
NIKNone listed
Oct 21, 2010Medtronic 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
NIKNone listed
Oct 21, 2010Medtronic 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
NIKNone listed
Oct 21, 2010Medtronic 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
NIKNone listed
Sep 27, 2010ela 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
NIKNone listed
May 8, 2010Boston 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
NIKNone listed
Nov 9, 2009Medtronic 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
NIKNone listed
Nov 9, 2009Medtronic 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
NIKNone listed
Jan 28, 2009Medtronic Inc. Cardiac Rhythm Managment
Maximo II CRT D284TRK, for ventricular pacing and defibrillation.
Terminated
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 11, 2007Boston 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
NIKNone listed
Jul 27, 2006Boston 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
NIKNone listed
Jul 27, 2006Boston 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
NIKNone listed
Jul 4, 2006Guidant 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
NIKNone listed
May 23, 2006Guidant 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
NIKNone listed
May 23, 2006Guidant 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
NIKNone listed
May 16, 2006Guidant 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
NIKNone listed
May 2, 2006Guidant 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
NIKNone listed
May 2, 2006Guidant 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
NIKNone listed
May 2, 2006Guidant 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
NIKNone listed
May 2, 2006Guidant 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
NIKNone listed
Nov 16, 2005St Jude Medical
Photo Micro VR/DR Models V-232
Terminated
NIKNone listed
Aug 3, 2005Guidant 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
NIKNone listed
Jul 19, 2005St 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
NIKNone listed
Jun 30, 2005Guidant 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
NIKNone listed
Jun 30, 2005Guidant 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
NIKNone listed
Jun 30, 2005Guidant 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
NIKNone listed
Jun 30, 2005Guidant 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
NIKNone listed
Jun 30, 2005Guidant 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
NIKNone listed
Jun 30, 2005Guidant 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
NIKNone listed
Jun 30, 2005Guidant 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
NIKNone listed
Apr 13, 2005St 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
NIKNone listed
Mar 11, 2005Medtronic 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
NIKNone listed

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