# K243224: MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Dec 31, 2024 after 85 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: 10 generations back to K893658 (1989). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241538: TriClip Steerable Guide Catheter, Abbott Medical (2024) Summary page 6.

## Indications for use
The MitraClip G5 Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. The TriClip G5 Steerable Guide Catheter is used for introducing various cardiovascular catheters into the right side of the heart.

Source page: https://510kreport.com/device/K243224
Methodology: https://510kreport.com/methodology