# K080425: CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Apr 23, 2008 after 68 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 K841802 (1984). 2 ancestors in all.
7 later devices descend from it; 4 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954390: Cordis Wester Star Catheter, Cordis Webster, Inc. (1995) Summary page 1.
- K841802: Electrode Catheter, Orthogonal Type, Webster Laboratories, Inc. (1984) Summary page 1.

## Most influential descendants
- K231312: PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID (2023), 3 descendants of its own
- K091780: Guided Measurement Catheter (GMC) (2009), 1 descendant of its own
- K241224: Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (2024), 0 descendants of its own
- K240826: Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (2024), 0 descendants of its own
- K233397: Cosine-10TM Diagnostic Catheter (2023), 0 descendants of its own

## Indications for use
The CS REFSTAR Catheter is indicated for electrophysiological mapping of cardiac structures ie., recording and stimulation, including the Coronary Sinus. In addition the CS REFSTAR Catheters are used with compatible CARTO EP Navigation Systems to provide catheter tip location information.

Source page: https://510kreport.com/device/K080425
Methodology: https://510kreport.com/methodology