# 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

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Dec 13, 2016 after 309 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: 2 generations back to K961924 (1997). 4 ancestors in all.
25 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042775: Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter, Irvine Biomedical, Inc. (2004) Summary page 4.
- K101955: ST Jude Medical Mediguide Enabled Livewire Steerable Electrophysiology Catheter, Model D402058, St Jude Medical (2010) Summary page 4.

## Most influential descendants
- 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
- K213364: EnSite X EP System (2021), 12 descendants of its own

## Indications for use
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart. The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information. The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is indicated for use as an adjunct to fluoroscopy.

Source page: https://510kreport.com/device/K160335
Methodology: https://510kreport.com/methodology