Cleared Traditional

CORPATH 200 SYSTEM

K120834 · Corindus, Inc. · Cardiovascular
Jul 2012
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K120834 is an FDA 510(k) clearance for the CORPATH 200 SYSTEM, a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Corindus, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 19, 2012, 122 days after receiving the submission on March 19, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K120834 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2012
Decision Date July 19, 2012
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