# K181458: Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Oct 27, 2018 after 145 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- 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: 3 generations back to K961924 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 5.

## Indications for use
The Reprocessed Advisor FL Circular Mapping Catheter 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/K181458
Methodology: https://510kreport.com/methodology