# K090898: Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with EZ Steer

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Sep 4, 2009 after 156 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: 1 generation back to K050877 (2005). 1 ancestor in all.
14 later devices descend from it; 4 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)
- K050877: Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR, Biosense Webster, Inc. (2005) Summary page 1.

## Most influential descendants
- K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04, (2010), 13 descendants of its own
- 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

## 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/K090898
Methodology: https://510kreport.com/methodology