# K161393: Reprocessed Orbiter ST Steerable Diagnostic EP Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Oct 26, 2016 after 160 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 K992373 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992373: Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable, C.R. Bard, Inc. (1999) Summary page 5.

## Indications for use
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Source page: https://510kreport.com/device/K161393
Methodology: https://510kreport.com/methodology