# K123714: Edwards Embol-X Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jul 24, 2013 after 232 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 K002973 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002973: Embol-X Introducer, Model CF00200, Embol-X, Inc. (2001) Summary page 1.

## Most influential descendants
- K140398: Embol-X Introducer Sheath (2014), 0 descendants of its own

## Indications for use
The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.

Source page: https://510kreport.com/device/K123714
Methodology: https://510kreport.com/methodology