# St. Jude Medical, Cardiac Rhythm Management Divisi

- Location (FDA's records): Sylmar, CA
- FDA decisions: 12 (1992–2012): 10 510(k) clearances and 2 original PMA approvals
- Product codes: DQY (4), DRB (2), DTB (1), MXC (1), DSA (1), DYB (1), DQX (1), DXY (1)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 14 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Medical: 6 (https://510kreport.com/company/abbott-medical)
- Mediguide, Ltd.: 2 (https://510kreport.com/company/mediguide)
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)
- Remington Medical, Inc.: 1 (https://510kreport.com/company/remington-medical)
- Brivant, Ltd.: 1 (https://510kreport.com/company/brivant)
- Lake Region Mfg., Inc.: 1 (https://510kreport.com/company/lake-region-mfg)

## Firms that cite its devices most
- St Jude Medical: 6 (https://510kreport.com/company/st-jude-medical)
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)
- Talon Surgical: 1 (https://510kreport.com/company/talon-surgical)
- Centerline Biomedical, Inc.: 1 (https://510kreport.com/company/centerline-biomedical)
- Epiep, Inc.: 1 (https://510kreport.com/company/epiep)
- Circa Scientific, Inc.: 1 (https://510kreport.com/company/circa-scientific)
- St Jude Medical, Crmd: 1 (https://510kreport.com/company/st-jude-medical-crmd)

## Its most-cited devices
- K111943: Agills PF Delivery System (2011), cited by 5
- K092075: CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 (2009), cited by 2
- K090613: CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 (2009), cited by 2
- K120298: CPS Excel Mediguide Enabled Guidewire (2012), cited by 2
- K122090: SJM Confirm Implantable Cardiac Monitor (2012), cited by 1
- K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A (2010), cited by 1

## Recent decisions
- K122090: SJM Confirm Implantable Cardiac Monitor (Nov 15, 2012)
- K120296: CPS Direct Mediguide Enabled Outer Catheter (May 11, 2012)
- K120298: CPS Excel Mediguide Enabled Guidewire (May 8, 2012)
- K111943: Agills PF Delivery System (Sep 29, 2011)
- K103250: CPS Direct SL II Slittable Outer Catheter (Jan 19, 2011)
- K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A (Apr 2, 2010)
- K092075: CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 (Aug 7, 2009)
- K090613: CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 (Jul 1, 2009)

Source page: https://510kreport.com/company/st-jude-medical-cardiac-rhythm-management-divisi