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FDA 510(k)

CorPath GRX System

K-Number: K173806 · 2018-03-01

ApplicantCorindus, Inc.
Decision Date2018-03-01
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CorPath GRX System is the device name listed in this FDA 510(k) record. The listed applicant is Corindus, Inc.. It received FDA 510(k) clearance on 2018-03-01 under 510(k) number K173806. 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 2018-03-01. The listed applicant is Corindus, Inc.. The 510(k) number is K173806.

When did CorPath GRX System receive FDA 510(k) clearance?

CorPath GRX System received FDA 510(k) clearance on 2018-03-01, under 510(k) number K173806.

Who is the listed applicant for CorPath GRX System?

The FDA 510(k) record lists Corindus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorPath GRX System?

The FDA product code for CorPath GRX System is DXX.

Other records listing Corindus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221464CorPath GRX SystemK202275CorPath GRX SystemK180517CorPath GRX SystemK173288CorPath GRX SystemK160121CorPath GRX SystemK152999CorPath 200 System

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Related Devices (Code: DXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.K221464CorPath GRX SystemCorindus, Inc.K202275CorPath GRX SystemCorindus, Inc.K180517CorPath GRX SystemCorindus, Inc.K173288CorPath GRX SystemCorindus, Inc.

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.

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