# K982740: Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'S 301-803A, 301-803P, 301-803M, 301-813S

- Pathway: 510(k) (Special)
- Applicant: Cordis Webster, Inc.
- Decided: Aug 28, 1998 after 22 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
Longest line of descent: 1 generation back to K970264 (1997). 1 ancestor in all.
40 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)
- K970264: Cordis Webster Braided Guiding Sheath Exchange System, Cordis Webster, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K212061: EnSite X EP System (2021), 13 descendants of its own

## Indications for use
The PREFACE Braided Guiding Sheath is intended for the introduction of intravascular electrophysiology catheters into any cardiac chamber. The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.

Source page: https://510kreport.com/device/K982740
Methodology: https://510kreport.com/methodology