# K954390: Cordis Wester Star Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Webster, Inc.
- Decided: Dec 21, 1995 after 93 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
No predicates in its family tree.
33 later devices descend from it; 5 cite it directly.
2 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070242: Soundstar 3D Ultrasound Catheter, Model M-5723-05 (2007), 14 descendants of its own
- K092064: Soundstar 3D Ultrasound Catheter, Model M-5723-12 (2009), 9 descendants of its own
- K081258: Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02 (2009), 7 descendants of its own
- K080425: CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02 (2008), 7 descendants of its own
- K112050: Soundstar Eco Diagnostic Ultrasound Catheter (2011), 5 descendants of its own

Source page: https://510kreport.com/device/K954390
Methodology: https://510kreport.com/methodology