# K241538: TriClip Steerable Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Aug 26, 2024 after 88 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K893658 (1989). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131063: Amplatzer Torq Vue LP Delivery System, St Jude Medical (2013) Summary page 4.
- K221397: MitraClip G4 Steerable Guide Catheter, Abbott Medical (2022) Summary page 4.

## Most influential descendants
- K243224: MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K241538
Methodology: https://510kreport.com/methodology