# K200258: Edwards eSheath Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Mar 9, 2020 after 35 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: 8 generations back to K924607 (1993). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152225: Edwards eSheath Introducer Set, Edwards Lifesciences (2015) Summary page 4.
- K162184: Edwards eSheath Introducer Set, Edward Lifesciences (2016) Summary page 4.

## Most influential descendants
- K244046: Edwards eSheath Optima introducer set (2025), 1 descendant of its own
- K252364: Edwards eSheath Optima introducer set (2025), 0 descendants of its own

## Indications for use
The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 and the SAPIEN 3 Ultra transcatheter heart valves.

Source page: https://510kreport.com/device/K200258
Methodology: https://510kreport.com/methodology