# K170668: HeartSpan Steerable Sheath Introducer

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Apr 5, 2017 after 30 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: 2 generations back to K122431 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132164: Heartspan Steerable Introducer Kit, Merit Medical Systems, Inc. (2013) Summary page 4.

## Indications for use
The HeartSpan® Steerable Sheath Introducer 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/K170668
Methodology: https://510kreport.com/methodology