Cleared Traditional

K150892 - CorPath 200 System
(FDA 510(k) Clearance)

K150892 · Corindus, Inc. · Cardiovascular
Oct 2015
Decision
183d
Days
Class 2
Risk

K150892 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. (Waltham, US). The FDA issued a Cleared decision on October 2, 2015, 183 days after receiving the submission on April 2, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K150892 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2015
Decision Date October 02, 2015
Days to Decision 183 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