# K120086: Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM

- Pathway: 510(k) (Traditional)
- Applicant: Cardiosolutions
- Decided: Apr 24, 2012 after 104 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002054 (2001). 13 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K042623: Agilis Steerable Catheter Introducer, Model 408304, St. Jude Medical, Daig Division, Inc. (2005) Summary page 1.
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST, Evalve, Inc. (2010) Summary page 1.

## Most influential descendants
- K131332: Cardiosolutions Percu-Pro Steerable Introducer (2013), 1 descendant of its own
- K140015: Cardiosolutions Dexterity Steerable Introducer (2014), 0 descendants of its own

## Indications for use
The Percu-ProTM 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/K120086
Methodology: https://510kreport.com/methodology