# K030944: Edwards Lifesciences Percutaneous Sheath Introducers with Oligon Material

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 20, 2003 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Edwards Lifesciences Percutaneous Sheath Introducers with Oligon material: named in the summary without a submission number
- (no number) Surgical Specialities’ Sharpoint DC-02 18 Suture: named in the summary without a submission number

## Indications for use
The Edwards Lifesciences Percutaneous Sheath Introducers with OligonTMmaterial are 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/K030944
Methodology: https://510kreport.com/methodology