# K121185: Edwards Percutaneous Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Aug 22, 2012 after 126 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 K981909 (1998). 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)
- K981909: Baxter Hemostasis Valve Introducers, Baxter Edwards (1998) Summary page 1.

## Most influential descendants
- K133296: XCATH (2014), 0 descendants of its own

## Indications for use
The Edwards Percutaneous Sheath Introducer is indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

Source page: https://510kreport.com/device/K121185
Methodology: https://510kreport.com/methodology