# K252364: Edwards eSheath Optima introducer set

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences
- Decided: Aug 29, 2025 after 31 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: 10 generations back to K924607 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K244046: Edwards eSheath Optima introducer set, Edwards Lifesciences (2025) Summary page 5.

## Indications for use
The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

Source page: https://510kreport.com/device/K252364
Methodology: https://510kreport.com/methodology