Cleared Traditional

NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500

K032937 · Stereotaxis, Inc. · Cardiovascular
Jul 2004
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K032937 is an FDA 510(k) clearance for the NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500, a System, Catheter Control, Steerable (Class II — Special Controls, product code DXX), submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on July 1, 2004, 283 days after receiving the submission on September 22, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K032937 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2003
Decision Date July 01, 2004
Days to Decision 283 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