CorPath GRX System
K-Number: K160121 · 2016-10-27
ApplicantCorindus, Inc.
Decision Date2016-10-27
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CorPath GRX System is a medical device manufactured by Corindus, Inc.. It received FDA 510(k) clearance on 2016-10-27 under approval number K160121. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CorPath GRX System?
CorPath GRX System is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by Corindus, Inc.. The 510(k) number is K160121.
When was CorPath GRX System approved by the FDA?
CorPath GRX System received FDA 510(k) clearance on 2016-10-27, under approval number K160121.
What company makes CorPath GRX System?
CorPath GRX System is manufactured by Corindus, Inc..
What is the FDA product code for CorPath GRX System?
The FDA product code for CorPath GRX System is DXX.
Other Devices by Corindus, Inc.
Related Devices (Code: DXX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.