# K160186: EnSite Velocity Surface Electrode Kit

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Oct 7, 2016 after 254 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: 5 generations back to K093942 (2010). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141050: Ensite Velocity System, St Jude Medical (2014) Summary page 4.

## Most influential descendants
- K201094: iMap 3D Mapping & Navigation System (iMap System) (2021), 0 descendants of its own

## Indications for use
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with an EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Source page: https://510kreport.com/device/K160186
Methodology: https://510kreport.com/methodology