# K161769: Reprocessed Supreme Diagnostic Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Dec 6, 2016 after 161 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- 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 K894500 (1989). 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)
- K002976: Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401XXX and 401XXX, St Jude Medical (2000) Summary page 5.
- K894500: Daig Electrophysiology Catheter, Daig Corp. (1989) Summary page 5.

## Indications for use
The Reprocessed Supreme Diagnostic Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Source page: https://510kreport.com/device/K161769
Methodology: https://510kreport.com/methodology