# K191170: Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Oct 30, 2019 after 182 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: 4 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)
- K072012: Reflexion Spiral Variable Radius Catheter, St Jude Medical (2007) Summary page 5.

## Indications for use
The Reprocessed Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The catheter is to be used to map the atrial regions of the heart.

Source page: https://510kreport.com/device/K191170
Methodology: https://510kreport.com/methodology