# K151622: St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jul 15, 2015 after 29 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913940 (1993). 11 ancestors in all.
11 later devices descend from it; 5 cite it directly.
7 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101955: ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model D402058, St Jude Medical (2010) Summary page 9.
- K150631: St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter, St Jude Medical (2015) Summary page 9.
- K913940: Response (TM) Steerable Catheter, Daig Corp. (1993) Summary page 10.
- K022380: Livesire Electrophysiology Catheter, St Jude Medical (2002) Summary page 10.
- K102721: Livewire Electophysiology Catheter, St Jude Medical (2010) Summary page 10.
- K914278: Daig Electrophysiology Catheter W/Infusion Lumen, Daig Corp. (1992) Summary page 11.
- K942379: Daig Diagnostic Electrophysiology Catheter, Daig Corp. (1994) Summary page 11.
- K120544: Response Electrophysiology Catheters with Lumen, St Jude Medical (2012) Summary page 11.
- K894500: Daig Electrophysiology Catheter, Daig Corp. (1989) Summary page 12.
- K002976: Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX and 401XXX, St Jude Medical (2000) Summary page 12.
- K081803: ST. Jude Medical Epicardial Catheter System, St Jude Medical (2009) Summary page 13.

## Most influential descendants
- K190106: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (2019), 6 descendants of its own
- K230309: Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (2023), 5 descendants of its own
- K242133: Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (2024), 3 descendants of its own
- K241243: Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (2024), 3 descendants of its own
- K243842: Intra-Operative Positioning System (IOPS®) (2025), 2 descendants of its own

## Indications for use
The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with MediGuide™ Technology to enable real-time tip positioning and navigation. The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy. The Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. St Jude Medical (SJM) Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart. St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Source page: https://510kreport.com/device/K151622
Methodology: https://510kreport.com/methodology