# K150357: Reprocessed Electrophysiology Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Aug 27, 2015 after 196 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: 3 generations back to K050877 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090898: Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with EZ Steer, Biosense Webster, Inc. (2009) Summary page 5.
- K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04,, Biosense Webster, Inc. (2010) Summary page 5.

## Indications for use
The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias. The catheter is designed for use in the coronary sinus.

Source page: https://510kreport.com/device/K150357
Methodology: https://510kreport.com/methodology