# K081803: ST. Jude Medical Epicardial Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: May 13, 2009 after 321 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
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
7 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Response Electrophysiology Catheter: named in the summary without a submission number
- (no number) Agilis NxT Steerable Introducer: named in the summary without a submission number

## Most influential descendants
- 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 (2015), 11 descendants of its own
- 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

## Indications for use
The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.

Source page: https://510kreport.com/device/K081803
Methodology: https://510kreport.com/methodology