Cleared Traditional

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM

K021555 · Stereotaxis, Inc. · Cardiovascular
Jan 2003
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K021555 is an FDA 510(k) clearance for the STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM, 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 January 15, 2003, 247 days after receiving the submission on May 13, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K021555 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2002
Decision Date January 15, 2003
Days to Decision 247 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