# K181056: Reprocessed CS Diagnostic Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Jan 24, 2019 after 279 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100254: Reprocessed CS BI-Diectional Diagnostic Electrophysiology Catheter, Ascent Healthcare Solutions (2010) Summary page 6.
- K090898: Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with EZ Steer, Biosense Webster, Inc. (2009) Summary page 6.
- 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 6.

## Indications for use
The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Source page: https://510kreport.com/device/K181056
Methodology: https://510kreport.com/methodology