# K060902: Starclose Introducer Set Model- 1002

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular, Inc.
- Decided: Jul 7, 2006 after 95 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jan 31, 2007 · Not classified · Z-0575-2007: Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.

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

Source page: https://510kreport.com/device/K060902
Methodology: https://510kreport.com/methodology