Cleared Traditional

CRONUS GUIDEWIRE, MODEL 001-001470-1

K051373 · Stereotaxis, Inc. · Neurology

Dec 2005

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K051373 is an FDA 510(k) clearance for the CRONUS GUIDEWIRE, MODEL 001-001470-1, a System, Catheter Or Guidewire, Steerable (magnetic) (Class II — Special Controls, product code NDQ), submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on December 9, 2005, 197 days after receiving the submission on May 26, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number	K051373 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 2005
Decision Date	December 09, 2005
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF