# K221397: MitraClip G4 Steerable Guide Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Sep 28, 2022 after 138 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: 2 generations back to K172394 (2017). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190167: MitraClip G4 Steerable Guide Catheter, Abbott (2019) Summary page 4.

## Most influential descendants
- K241538: TriClip Steerable Guide Catheter (2024), 1 descendant of its own
- 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 left side of the heart through interatrial septum.

Source page: https://510kreport.com/device/K221397
Methodology: https://510kreport.com/methodology