ClearanceBrief
Company ยท US

St Jude Medical CRMD

FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2010. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
44recalls (0 in 12 months)
7recalls that name a 510(k)

Product codes

CodeDeviceRecords
DQYCatheter, Percutaneous5
DXYImplantable Pacemaker Pulse-Generator3
KRGProgrammer, Pacemaker2
LWSImplantable Cardioverter Defibrillator (Non-Crt)2
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)2
DTATester, Pacemaker Electrode Function1
MCXCatheter, Coronary, Atherectomy1
MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 21, 2010K101982MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
St Jude Medical, Crmd
DTA

Latest recalls

DateFirm and productCodeLinked 510(k)
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
Jan 11, 2012St Jude Medical CRMD
St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous high voltage (HV) le
Terminated
LWSNone listed
Jan 11, 2012St Jude Medical CRMD
St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable
Terminated
LWSNone listed
Jan 11, 2012St Jude Medical CRMD
Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
Terminated
DXYNone listed
Jan 11, 2012St Jude Medical CRMD
Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
Terminated
DXYNone listed
Jul 5, 2011St Jude Medical CRMD
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing i
Terminated
MXCK081365
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-367
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-366
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-365
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy cardioverter/defibrillator, Model V-268
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II DR Tiered-therapy cardioverter/defibrillator, Model V-265
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II VR Tiered-therapy cardioverter/defibrillator, Model V-168
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-343
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-340
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillator with biventricular strimulation, Model V-341
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + DR Tiered-therapy cardioverter/defibrillator, Model V-243
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS DR Tiered-therapy cardioverter/defibrillator, Model V-242
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + VR Tiered-therapy cardioverter/defibrillator, Model V-193
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-356
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-357
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-355
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II+ DR Tiered-therapy cardioverter/defibrillator, Model V-258
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II DR Tiered-therapy cardioverter/defibrillator, Model V-255
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II VR Tiered-therapy cardioverter/defibrillator, Model V-158
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC + HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-350
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-239
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-236
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy cardioverter/defibrillator, Model V-233
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy cardioverter/defibrillator, Model V-196
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-339
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC HF Tiered-Therapy Cardioverter/Defibrillator with Biventricular Stimulation, Model V-338
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-337
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC DR Tiered-Therapy Cardioverter/Defibrillator, Model V-235
Terminated
None listed
Aug 19, 2008St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197
Terminated
None listed
Jun 14, 2007St Jude Medical CRMD
St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.
Terminated
MCXK053277
Dec 19, 2006St Jude Medical CRMD
St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
Terminated
DXYNone listed
Dec 19, 2006St Jude Medical CRMD
St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
Terminated
KRGNone listed
Dec 19, 2006St Jude Medical CRMD
St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
Terminated
KRGNone listed
Jun 24, 2006St Jude Medical CRMD
CPS Implant Kit, Model 410190
Terminated
DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148
Terminated
DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126
Terminated
DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Valve Bypass Tool (VBT), Model 410192
Terminated
DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Slitter, Model 410191
Terminated
DQYK053217
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