# K061070: Hansen Medical Transseptal Needle and Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Hansen Medical, Inc.
- Decided: Oct 13, 2006 after 179 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- 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 K932619 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011727: Transseptal Needle/Trocar, Thomas Medical Products, Inc. (2002) Summary page 1.
- K020090: Modification to Transseptal Introducer Set, Thomas Medical Products, Inc. (2002) Summary page 1.
- (no number) Daig Corp., BRK Transseptal Needle: named in the summary without a submission number

## Most influential descendants
- K082075: Hansen Medical Dilator for Artisan Control Catheter (2008), 0 descendants of its own

## Indications for use
The Hansen Medical Transseptal Needle and dilator are intended to create the primary puncture in the interatrial septum for passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

Source page: https://510kreport.com/device/K061070
Methodology: https://510kreport.com/methodology