# K171788: Reprocessed Halo XP Diagnostic Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Nov 3, 2017 after 141 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: 1 generation back to K953768 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953768: Cordis Webster A20 Diagnostic Deflectable Tip Catheter, Cordis Webster, Inc. (1995) Summary page 5.
- K953663: Cordis Webster T20 Diagnostic Deflectable Tip Catheter, Cordis Webster, Inc. (1996) Summary page 5.

## Indications for use
The Reprocessed Halo XP Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheters’ preformed halo shape of the tip section is designed specifically for the tricuspid annulus.

Source page: https://510kreport.com/device/K171788
Methodology: https://510kreport.com/methodology