# K932619: Transseptal Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Aug 24, 1993 after 84 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020090: Modification to Transseptal Introducer Set (2002), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K932619
Methodology: https://510kreport.com/methodology