# K031583: Modification to Ivs Introducer Set, Model 1003

- Pathway: 510(k) (Special)
- Applicant: Integrated Vascular Systems, Inc.
- Decided: Jun 16, 2003 after 26 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: 2 generations back to K020879 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030723: Ivs Introducer Set, Model 1003, Integrated Vascular Systems, Inc. (2003) Summary page 1.

## Indications for use
The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.

Source page: https://510kreport.com/device/K031583
Methodology: https://510kreport.com/methodology