# K970264: Cordis Webster Braided Guiding Sheath Exchange System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Webster, Inc.
- Decided: Oct 28, 1997 after 278 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 1 cites it directly.
1 of 42 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis 9 FR Guiding Catheter: named in the summary without a submission number
- (no number) Daig Fast-Cath™ Hemostasis Introducer: named in the summary without a submission number

## Most influential descendants
- K982740: Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'S 301-803A, 301-803P, 301-803M, 301-813S (1998), 40 descendants of its own
- K050217: Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing) (2005), 39 descendants of its own
- K120425: Pentaray Nav High-Density Mapping Catheter (2012), 34 descendants of its own
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled (2018), 21 descendants of its own
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (2020), 17 descendants of its own

## Indications for use
Introduction of intravascular electrophysiology catheters into any cardiac chamber.

Source page: https://510kreport.com/device/K970264
Methodology: https://510kreport.com/methodology