CRONUS GUIDEWIRE, MODEL 001-001470-1

System, Catheter Or Guidewire, Steerable (magnetic)

STEREOTAXIS, INC.

The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Cronus Guidewire, Model 001-001470-1.

Pre-market Notification Details

Device IDK051373
510k NumberK051373
Device Name:CRONUS GUIDEWIRE, MODEL 001-001470-1
ClassificationSystem, Catheter Or Guidewire, Steerable (magnetic)
Applicant STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis,  MO  63108
ContactKelly Rowland
CorrespondentKelly Rowland
STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis,  MO  63108
Product CodeNDQ  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-26
Decision Date2005-12-09
Summary:summary

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