STEREOTAXIS ENDOVASCULAR GUIDE WIRE

Wire, Guide, Catheter

STEREOTAXIS, INC.

The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Stereotaxis Endovascular Guide Wire.

Pre-market Notification Details

Device IDK042854
510k NumberK042854
Device Name:STEREOTAXIS ENDOVASCULAR GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis,  MO  63108
ContactGary Rauvola
CorrespondentGary Rauvola
STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis,  MO  63108
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-15
Decision Date2005-02-08
Summary:summary

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