# K140015: Cardiosolutions Dexterity Steerable Introducer

- Pathway: 510(k) (Special)
- Applicant: Cardiosolutions, Inc.
- Decided: Feb 5, 2014 after 34 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: 9 generations back to K002054 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM, Cardiosolutions (2012) Summary page 2.
- K131332: Cardiosolutions Percu-Pro Steerable Introducer, Cardiosolutions, Inc. (2013) Summary page 2.

## Indications for use
The DexterityTM Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

Source page: https://510kreport.com/device/K140015
Methodology: https://510kreport.com/methodology