Microcatheter

Catheter, Percutaneous

Surmodics, Inc.

The following data is part of a premarket notification filed by Surmodics, Inc. with the FDA for Microcatheter.

Pre-market Notification Details

Device IDK173560
510k NumberK173560
Device Name:Microcatheter
ClassificationCatheter, Percutaneous
Applicant Surmodics, Inc. 9924 W 74th St Eden Prairie,  MN  55344
ContactSherri Mellingen
CorrespondentSherri Mellingen
Surmodics, Inc. 9924 W 74th St Eden Prairie,  MN  55344
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-17
Decision Date2018-01-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.