# K221464: CorPath GRX System

- Pathway: 510(k) (Special)
- Applicant: Corindus, Inc.
- Decided: Jul 27, 2022 after 69 days
- Product code: DXX (System, Catheter Control, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K900765 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202275: CorPath GRX System, Corindus, Inc. (2020) Summary page 4.

## Indications for use
The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

Source page: https://510kreport.com/device/K221464
Methodology: https://510kreport.com/methodology