# K112239: Steerable Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Aug 31, 2011 after 27 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.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083793: Steerable Guide Catheter, Evalve, Inc. (2009) Summary page 1.
- K091596: Evalve Steerable Guide Catheter, Model SGC01ST, Evalve, Inc. (2009) Summary page 1.
- K093866: Evalve Steerable Guide Catheter, Evalve, Inc. (2010) Summary page 1.
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST, Evalve, Inc. (2010) Summary page 1.

## Most influential descendants
- K161985: Steerable Guide Catheter (2016), 0 descendants of its own

## Indications for use
The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K112239
Methodology: https://510kreport.com/methodology