# K030723: Ivs Introducer Set, Model 1003

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Vascular Systems, Inc.
- Decided: Apr 3, 2003 after 27 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 K020879 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020879: Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001, Integrated Vascular Systems, Inc. (2002). Our reading of the summary gave K020789, FDA’s number for GE Vivid 3 Expert; GE Vivid 3 Pro (General Electric Co.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “IVS Introducer Set, Model 1001”. Summary page 1.

## Most influential descendants
- K060902: Starclose Introducer Set Model- 1002 (2006), 0 descendants of its own
- K031583: Modification to Ivs Introducer Set, Model 1003 (2003), 0 descendants of its own

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

Source page: https://510kreport.com/device/K030723
Methodology: https://510kreport.com/methodology