# K031087: Edwards Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 24, 2003 after 17 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 K902469 (1990). 2 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902469: Byrd Dilator Sheath Set - Teflon, Medical Engineering and Development Institute (1990) Summary page 1.
- K003889: Ancure Sheath Model # 40315, 40320, 40325, Guidant Cardiac and Vascular Surgery (2002) Summary page 1.

## Most influential descendants
- K093877: Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 (2010), 16 descendants of its own
- K140338: Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large) (2014), 8 descendants of its own
- K180785: iSLEEVE Introducer Set (2018), 7 descendants of its own
- K191871: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (2019), 4 descendants of its own
- K152225: Edwards eSheath Introducer Set (2015), 4 descendants of its own

## Indications for use
The Edwards Introducer Sheath is designed to facilitate the entry of interventional devices into the human vascular system.

Source page: https://510kreport.com/device/K031087
Methodology: https://510kreport.com/methodology