Cleared Traditional

CorPath GRX System

K202275 · Corindus, Inc. · Cardiovascular
Dec 2020
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K202275 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 December 11, 2020, 122 days after receiving the submission on August 11, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K202275 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2020
Decision Date December 11, 2020
Days to Decision 122 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