# K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Inc.
- Decided: Apr 23, 2018 after 258 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- 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: 5 generations back to K983171 (1999). 16 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120425: Pentaray Nav High-Density Mapping Catheter, Biosense Webster, Inc. (2012) Summary page 4.
- 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 4.

## Most influential descendants
- 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
- 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

## Indications for use
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/K172393
Methodology: https://510kreport.com/methodology