# K141696: Edwards Esheath Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Sep 18, 2014 after 86 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: 3 generations back to K902469 (1990). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093877: Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26, Edwards Lifesciences, LLC (2010) Summary page 4.
- K100819: The Solopath Balloon Expandable Transfemoral Introducer, Onset Medical Corporation (2010) Summary page 4.

## Most influential descendants
- K152054: Confida Adaptive Sheath (2015), 0 descendants of its own

## Indications for use
The Edwards eSheath Introducer Set is indicated for the introduction of the Edwards SAPIEN XT Transcatheter Heart Valve and associated devices into the vascular system.

Source page: https://510kreport.com/device/K141696
Methodology: https://510kreport.com/methodology