# K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04,

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jun 22, 2010 after 40 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050877 (2005). 2 ancestors in all.
13 later devices descend from it; 9 cite it directly.
1 of 16 devices in its family (counting itself) has 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 2.

## 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
- K101991: Webster Duo-Decapolar  Catheter (2011), 3 descendants of its own
- K190980: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (2019), 1 descendant of its own
- K170922: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (2017), 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

## Recalls of this device
- Dec 15, 2007 · Not classified · Z-1647-2012: The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.

## Indications for use
The Webster CS 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/K101345
Methodology: https://510kreport.com/methodology