# K050877: Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Jun 24, 2005 after 79 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.
16 later devices descend from it; 2 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K892265: Biosense Webster Deflectable Mapping Catheter. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K090898: Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with EZ Steer (2009), 14 descendants of its own
- 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

## Indications for use
The Coronary Sinus Deflectable Mapping Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only.

Source page: https://510kreport.com/device/K050877
Methodology: https://510kreport.com/methodology