Cleared Special

CorPath GRX System

K180517 · Corindus, Inc. · Cardiovascular
Mar 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K180517 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 29, 2018, 30 days after receiving the submission on February 27, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K180517 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2018
Decision Date March 29, 2018
Days to Decision 30 days
Submission Type Special
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