# K160121: CorPath GRX System

- Pathway: 510(k) (Traditional)
- Applicant: Corindus, Inc.
- Decided: Oct 27, 2016 after 282 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: 9 generations back to K900765 (1990). 12 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120834: Corpath 200 System, Corindus, Inc. (2012) Summary page 4.
- K150892: CorPath 200 System, Corindus, Inc. (2015) Summary page 4.

## Most influential descendants
- K173806: CorPath GRX System (2018), 2 descendants of its own
- K202275: CorPath GRX System (2020), 1 descendant of its own
- K173288: CorPath GRX System (2018), 1 descendant of its own
- K221464: CorPath GRX System (2022), 0 descendants of its own
- K180517: CorPath GRX System (2018), 0 descendants of its own

## Indications for use
The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Source page: https://510kreport.com/device/K160121
Methodology: https://510kreport.com/methodology