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 IDK221464
510k NumberK221464
Device Name:CorPath GRX System
ClassificationSystem, Catheter Control, Steerable
Applicant Corindus, Inc. 309 Waverley Oaks Road, Suite 105 Waltham,  MA  02452
ContactRobert Lavado
CorrespondentRobert Lavado
Corindus, Inc. 309 Waverley Oaks Road, Suite 105 Waltham,  MA  02452
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-19
Decision Date2022-07-27

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