510(k) Report

FDA applicant

St. Jude Medical, Cardiac Rhythm Management Divisi

Sylmar, CA12 decisions1992–20120 recalls

FDA records 12 decisions for St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, CA) from 1992 to 2012: 10 510(k) clearances and 2 original PMA approvals. Most are in product codes DQY (Catheter, Percutaneous) and DRB (Stylet, Catheter). Its devices cite 13 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided St. Jude Medical, Cardiac Rhythm Management Divisi’s devices, and how often a recall has named them.

FDA decisions per year

3in 2012

2008: 22009: 22010: 12011: 22012: 3
2007high 3 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — St. Jude Medical, Cardiac Rhythm Management Divisi by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQYCatheter, Percutaneous4decisions
  • DRBStylet, Catheter2decisions
  • DTBPermanent Pacemaker Electrode1decision
  • MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • DYBIntroducer, Catheter1decision

Also: DQX (1), DXY (1).

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111943Agills PF Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi · 20115cite it
  • K092075CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005St. Jude Medical, Cardiac Rhythm Management Divisi · 20092cite it
  • K090613CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65…St. Jude Medical, Cardiac Rhythm Management Divisi · 20092cite it
  • K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 20122cite it
  • K122090SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi · 20121cites it
  • K093858Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 20101cites it

What has FDA decided for it lately?

  • K122090SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K111943Agills PF Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi · 2011
  • K103250CPS Direct SL II Slittable Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2011
  • K093858Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 2010
  • K092075CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005St. Jude Medical, Cardiac Rhythm Management Divisi · 2009
  • K090613CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65…St. Jude Medical, Cardiac Rhythm Management Divisi · 2009

All 12 as St. Jude Medical, Cardiac Rhythm Management Divisi →