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)
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
Open, Classified
NIKNone listed
Aug 9, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC
Open, Classified
NIKNone listed
Aug 9, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Open, Classified
NIKNone listed
Aug 9, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, D
Open, Classified
NIKNone listed
Aug 9, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Open, Classified
NIKNone listed
Aug 9, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA
Open, Classified
NIKNone listed
Jul 28, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Open, Classified
NIKNone listed
Jul 7, 2022Boston Scientific Corporation
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functi
Open, Classified
NIKNone listed
Apr 12, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Co
Open, Classified
NIKNone listed
Mar 10, 2022St. Jude Medical, Cardiac Rhythm Management Division
Merlin 2 PCS MER3700 programmer Model MER3400 software
Open, Classified
NIKNone listed
Apr 7, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a pa
Terminated
NIKNone listed
Apr 6, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment o
Open, Classified
NIKNone listed
Apr 6, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 20
Open, Classified
NIKNone listed
Apr 6, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronizati
Open, Classified
NIKNone listed
Apr 6, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of hea
Open, Classified
NIKNone listed
Mar 27, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D
Open, Classified
NIKNone listed
Nov 15, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Terminated
NIKNone listed
Nov 15, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE
Terminated
NIKNone listed
Nov 15, 2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wire
Terminated
NIKNone listed
Feb 28, 2020Abbott
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program
Terminated
NIKNone listed
Jul 9, 2018Sorin CRM SAS
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Terminated
NIKNone listed
Jul 9, 2018Sorin CRM SAS
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Terminated
NIKNone listed
Apr 16, 2018St Jude Medical Inc.
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/1
Terminated
NIKNone listed
Apr 16, 2018St Jude Medical Inc.
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/1
Terminated
NIKNone listed
Apr 16, 2018St Jude Medical Inc.
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897
Terminated
NIKNone listed
Apr 16, 2018St Jude Medical Inc.
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080
Terminated
NIKNone listed
Apr 16, 2018St Jude Medical Inc.
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 1
Terminated
NIKNone listed
Feb 1, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ);
Terminated
NIKNone listed
Feb 1, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Vi
Terminated
NIKNone listed
Feb 1, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ )
Terminated
NIKNone listed
Feb 1, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1);
Terminated
NIKNone listed
Oct 10, 2017St Jude Medical Inc.
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model
Terminated
NIKNone listed
Oct 4, 2017Boston Scientific Corporation
RESONATE X4 CRT-D, Model G447, Sterile.
Terminated
NIKNone listed
Oct 4, 2017Boston Scientific Corporation
MOMENTUM X4 CRT-D, Model G138, Sterile.
Terminated
NIKNone listed

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