SOFIA DISTAL ACCESS CATHETER

Catheter, Percutaneous

MICRO VENTION, INC.

The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Sofia Distal Access Catheter.

Pre-market Notification Details

Device IDK131482
510k NumberK131482
Device Name:SOFIA DISTAL ACCESS CATHETER
ClassificationCatheter, Percutaneous
Applicant MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
ContactNaomi Gong
CorrespondentNaomi Gong
MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-23
Decision Date2013-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987350999795 K131482 000
00816777025913 K131482 000
00810170019623 K131482 000
00810170019234 K131482 000

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