# 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

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Nov 25, 2020 after 121 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K000248 (2000). 53 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201181: EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System, Abbott Medical (2020) Summary page 5.
- K192037: Advisor VL Circular Mapping Catheter, Sensor Enabled, Abbott Medical (2019) Summary page 6.
- 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, St Jude Medical (2016) Summary page 7.
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled, St. Jude Medical, Inc. (2018) Summary page 7.

## Most influential descendants
- K212061: EnSite X EP System (2021), 13 descendants of its own
- K213364: EnSite X EP System (2021), 12 descendants of its own
- K221213: EnSite X EP System (2022), 11 descendants of its own
- K223094: EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License (2022), 10 descendants of its own
- K231415: EnSite™ X EP System (2023), 9 descendants of its own

## Indications for use
EnSite™ X EP System: The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures. EnSite™ X EP System Contact Force Software License: When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters. EnSite™ X EP System Surface Electrode Kit: The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use. Advisor™ VL Circular Mapping Catheter, Sensor Enabled™: Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ is a steerable electrophysiology catheter with integrated sensors. The catheter is 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. Advisor™ FL Circular Mapping Catheter, Sensor Enabled™: The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is steerable electrophysiology catheter with integrated sensors. The catheter is 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. Advisor™ HD High Density Mapping Catheter, Sensor Enabled™: The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Source page: https://510kreport.com/device/K202066
Methodology: https://510kreport.com/methodology