# K131332: Cardiosolutions Percu-Pro Steerable Introducer

- Pathway: 510(k) (Special)
- Applicant: Cardiosolutions, Inc.
- Decided: Jul 19, 2013 after 71 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: 8 generations back to K002054 (2001). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.

## Most influential descendants
- K140015: Cardiosolutions Dexterity Steerable Introducer (2014), 0 descendants of its own

## Indications for use
The Percu-ProTh Steerable Introducer is intended to be used for the 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/K131332
Methodology: https://510kreport.com/methodology