Cleared Traditional

ODYSSEY WORKSTATION

K072371 · Stereotaxis, Inc. · Cardiovascular
Nov 2007
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K072371 is an FDA 510(k) clearance for the ODYSSEY WORKSTATION, a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 14, 2007, 83 days after receiving the submission on August 23, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K072371 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2007
Decision Date November 14, 2007
Days to Decision 83 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