# K092158: Reprocessed Electrophysiology Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jan 14, 2010 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) St. Jude Medical Reflexion catheters: named in the summary without a submission number

## Indications for use
The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

Source page: https://510kreport.com/device/K092158
Methodology: https://510kreport.com/methodology