CorPath GRX System

System, Catheter Control, Steerable

Corindus, Inc.

The following data is part of a premarket notification filed by Corindus, Inc. with the FDA for Corpath Grx System.

Pre-market Notification Details

Device IDK180517
510k NumberK180517
Device Name:CorPath GRX System
ClassificationSystem, Catheter Control, Steerable
Applicant Corindus, Inc. 309 Waverley Oaks Road Waltham,  MA  02452
ContactRobert Lavado
CorrespondentRobert Lavado
Corindus, Inc. 309 Waverley Oaks Road Waltham,  MA  02452
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-27
Decision Date2018-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816280023123 K180517 000

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