# K132164: Heartspan Steerable Introducer Kit

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Sep 17, 2013 after 67 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 K122431 (2013). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K122431: Heartspan Steerable Introducer Kit, Thomas Medical Products, Inc. (2013) Summary page 3.

## Most influential descendants
- 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

## Indications for use
The HeartSpan Steerable Introducer Kit is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K132164
Methodology: https://510kreport.com/methodology