# K040728: Angiodynamics, Inc., Percutaneous Introducer and Elvs Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jun 18, 2004 after 88 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature. AngioDynamics, Inc. Percutaneous Introducers are designed for use during catheterization procedures and are not intended for critical care use.

Source page: https://510kreport.com/device/K040728
Methodology: https://510kreport.com/methodology