# K120834: Corpath 200 System

- Pathway: 510(k) (Traditional)
- Applicant: Corindus, Inc.
- Decided: Jul 19, 2012 after 122 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: 7 generations back to K900765 (1990). 10 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060967: Niobe Magnetic Navigation System W/Navigant Workstation, Stereotaxis, Inc. (2006) Summary page 1.
- K091808: Sensei Robotic Catheter System, Model 02057, Hansen Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K150892: CorPath 200 System (2015), 7 descendants of its own
- K160121: CorPath GRX System (2016), 5 descendants of its own
- K173806: CorPath GRX System (2018), 2 descendants of its own
- K152999: CorPath 200 System (2016), 2 descendants of its own
- K202275: CorPath GRX System (2020), 1 descendant of its own

## Indications for use
The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.

Source page: https://510kreport.com/device/K120834
Methodology: https://510kreport.com/methodology