VDRIVE WITH V-LOOP/ VDRIVE DUO

System, Catheter Control, Steerable

STEREOTAXIS, INC.

The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Vdrive With V-loop/ Vdrive Duo.

Pre-market Notification Details

Device IDK140804
510k NumberK140804
Device Name:VDRIVE WITH V-LOOP/ VDRIVE DUO
ClassificationSystem, Catheter Control, Steerable
Applicant STEREOTAXIS, INC. 2995 STEVEN MARTIN DR, Fairfax,  VA  22031
ContactDiane Horwitz, Ph.d., Rac
CorrespondentDiane Horwitz, Ph.d., Rac
STEREOTAXIS, INC. 2995 STEVEN MARTIN DR, Fairfax,  VA  22031
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-31
Decision Date2014-09-03
Summary:summary

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