# K082075: Hansen Medical Dilator for Artisan Control Catheter

- Pathway: 510(k) (Special)
- Applicant: Hansen Medical, Inc.
- Decided: Aug 15, 2008 after 23 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: 3 generations back to K932619 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061070: Hansen Medical Transseptal Needle and Dilator, Hansen Medical, Inc. (2006) Summary page 1.

## Indications for use
The Dilator for ArtisanTM Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side,

Source page: https://510kreport.com/device/K082075
Methodology: https://510kreport.com/methodology