# K020090: Modification to Transseptal Introducer Set

- Pathway: 510(k) (Special)
- Applicant: Thomas Medical Products, Inc.
- Decided: Feb 11, 2002 after 32 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 K932619 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K932619: Transseptal Introducer Set, Thomas Medical Products, Inc. (1993) Summary page 1.

## Most influential descendants
- K061070: Hansen Medical Transseptal Needle and Dilator (2006), 1 descendant of its own
- K082075: Hansen Medical Dilator for Artisan Control Catheter (2008), 0 descendants of its own

## Indications for use
For the introduction of various types of cardiovascular catheters into the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K020090
Methodology: https://510kreport.com/methodology