St. Jude Medical, Cardiac Rhythm Management Divisi
Sylmar, CA, US
St. Jude Medical, Cardiac Rhythm Management Divisi appears in FDA device records in Sylmar, CA. FDA records list 10 510(k) clearances between and , 32 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 32
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for St. Jude Medical, Cardiac Rhythm Management Divisi between 2008 and 2012. The busiest year on record is 2012, with 3. The most recent is 2012, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | MXC | Substantially Equivalent | |
| K120296 | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER | DQY | Substantially Equivalent | |
| K120298 | CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE | DQX | Substantially Equivalent | |
| K111943 | AGILLS PF DELIVERY SYSTEM | DYB | Substantially Equivalent | |
| K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER | DQY | Substantially Equivalent | |
| K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A | DSA | Substantially Equivalent | |
| K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 | DQY | Substantially Equivalent | |
| K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 | DQY | Substantially Equivalent | |
| K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | DRB | Substantially Equivalent | |
| K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | DRB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- DQYCatheter, Percutaneous
- DXYImplantable Pacemaker Pulse-Generator
- DYBIntroducer, Catheter
- DTBPermanent Pacemaker Electrode
- KRGProgrammer, Pacemaker
- NVZPulse Generator, Permanent, Implantable
- MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
- DRBStylet, Catheter
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain