# K131627: Catheter Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Mar 6, 2014 after 275 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.

Source page: https://510kreport.com/device/K131627
Methodology: https://510kreport.com/methodology