SCEPTER XC OCCLUSION BALLOON CATHETER

Catheter, Intravascular Occluding, Temporary

MICRO VENTION, INC.

The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Scepter Xc Occlusion Balloon Catheter.

Pre-market Notification Details

Device IDK113698
510k NumberK113698
Device Name:SCEPTER XC OCCLUSION BALLOON CATHETER
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
ContactNaomi Gong
CorrespondentNaomi Gong
MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
Product CodeMJN  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-16
Decision Date2012-01-13
Summary:summary

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