Cleared Traditional

CorPath GRX System

K173806 · Corindus, Inc. · Cardiovascular
Mar 2018
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K173806 is an FDA 510(k) clearance for the CorPath GRX System, a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Corindus, Inc. (Waltham, US). The FDA issued a Cleared decision on March 1, 2018, 76 days after receiving the submission on December 15, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K173806 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2017
Decision Date March 01, 2018
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXX — System, Catheter Control, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1290