# K101991: Webster Duo-Decapolar  Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: May 2, 2011 after 292 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: 3 generations back to K050877 (2005). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953768: Cordis Webster A20 Diagnostic Deflectable Tip Catheter, Cordis Webster, Inc. (1995) Summary page 1.
- K090898: Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with EZ Steer, Biosense Webster, Inc. (2009) Summary page 1.
- K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04,, Biosense Webster, Inc. (2010) Summary page 2.

## Most influential descendants
- K190980: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (2019), 1 descendant of its own
- K240826: Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (2024), 0 descendants of its own
- K233825: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (2024), 0 descendants of its own

## Indications for use
The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. In addition, the Webster Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.

Source page: https://510kreport.com/device/K101991
Methodology: https://510kreport.com/methodology