# K152225: Edwards eSheath Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Nov 24, 2015 after 109 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: 6 generations back to K924607 (1993). 13 ancestors in all.
4 later devices descend from it; 2 cite 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)
- 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.
- K142829: Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer, Cook Incorporated (2015) Summary page 5.

## Most influential descendants
- K162184: Edwards eSheath Introducer Set (2016), 3 descendants of its own
- K200258: Edwards eSheath Introducer Set (2020), 2 descendants of its own
- 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 Transcatheter Heart Valve.

Source page: https://510kreport.com/device/K152225
Methodology: https://510kreport.com/methodology