STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM

System, Catheter Control, Steerable

STEREOTAXIS, INC.

The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Stereotaxis Niobe Magnetic Navigation System.

Pre-market Notification Details

Device IDK021555
510k NumberK021555
Device Name:STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
ClassificationSystem, Catheter Control, Steerable
Applicant STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis,  MO  63108
ContactPeter A Takes
CorrespondentPeter A Takes
STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis,  MO  63108
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-13
Decision Date2003-01-15
Summary:summary

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