# K122431: Heartspan Steerable Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Jan 29, 2013 after 172 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K132164: Heartspan Steerable Introducer Kit (2013), 3 descendants of its own
- K142684: FlexCath Select Steerable Sheath (10 French) (2014), 1 descendant of its own
- K170668: HeartSpan Steerable Sheath Introducer (2017), 0 descendants of its own
- K163268: FlexCath Select Steerable Shealth and Dilator (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K122431
Methodology: https://510kreport.com/methodology