# K062554: Starclose Hex-Hub Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular, Inc.
- Decided: Feb 6, 2007 after 160 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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 K954234 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840641: Vessel Dilator, Aries Medical, Inc. (1984) Summary page 1.
- K052557: Super Sheath Introducer Sheath, Togo Medikit Co., Ltd. (2006) Summary page 1.

## Indications for use
The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices.

Source page: https://510kreport.com/device/K062554
Methodology: https://510kreport.com/methodology