# K983940: EZ-Intro Percutaneous Catheter Sheath, EZ-Intro Vessel Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Adam Spence Corp.
- Decided: Jul 15, 1999 after 252 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 K964518 (1997). 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)
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 1.

## Indications for use
The Adam Spence Percutaneous Catheter Introducer is intended to provide a means for percutaneous vascular access while minimizing the back flow of blood during the introduction of cardiovascular devices such as catheters and guide wires.

Source page: https://510kreport.com/device/K983940
Methodology: https://510kreport.com/methodology