# K161985: Steerable Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Aug 7, 2016 after 19 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: 8 generations back to K002054 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
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 4.
- K091596: Evalve Steerable Guide Catheter, Model SGC01ST, Evalve, Inc. (2009) Summary page 4.
- K093866: Evalve Steerable Guide Catheter, Evalve, Inc. (2010) Summary page 4.
- K100789: Modificaton to: Steerable Guide Catheter, Model SGC01ST, Evalve, Inc. (2010) Summary page 4.
- K112239: Steerable Guide Catheter, Abbott Vascular (2011) Summary page 4.

## 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/K161985
Methodology: https://510kreport.com/methodology