# K953768: Cordis Webster A20 Diagnostic Deflectable Tip Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Webster, Inc.
- Decided: Nov 22, 1995 after 100 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 7 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- 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
- K171788: Reprocessed Halo XP Diagnostic Electrophysiology Catheter (2017), 0 descendants of its own

## Recalls of this device
- May 23, 2011 · Not classified · Z-2664-2011: The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
- May 23, 2011 · Not classified · Z-2665-2011: The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
- Apr 29, 2011 · Not classified · Z-3038-2011: The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the e
- Apr 29, 2011 · Not classified · Z-3037-2011: The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the e

Source page: https://510kreport.com/device/K953768
Methodology: https://510kreport.com/methodology