# K101955: ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model D402058

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Oct 15, 2010 after 95 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.
39 later devices descend from it; 3 cite it directly.
7 of 40 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) St. Jude Medical Livewire Electrophysiology Catheter: named in the summary without a submission number
- (no number) MediGuide Guided Measurement Catheter (GMC): named in the summary without a submission number

## Most influential descendants
- K160335: Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (2016), 25 descendants of its own
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled (2018), 21 descendants of its own
- K192037: Advisor VL Circular Mapping Catheter, Sensor Enabled (2019), 18 descendants of its own
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (2020), 17 descendants of its own
- K212061: EnSite X EP System (2021), 13 descendants of its own

## Indications for use
The SJM MediGuide Enabled Livewire TM steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The MediGuide Enabled Livewire TM Steerable Electrophysiology Catheter is used with a compatible gMPSTM system to enable real-time tip positioning and navigation. The MediGuide System is indicated for use as an adjunct to fluoroscopy

Source page: https://510kreport.com/device/K101955
Methodology: https://510kreport.com/methodology