MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, And GALAXY G3 Mini Microcoil Delivery Systems

Device, Neurovascular Embolization

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Micrusframe, Deltafill, Deltaxsft, Galaxy G3, Galaxy G3 Xsft, And Galaxy G3 Mini Microcoil Delivery Systems.

Pre-market Notification Details

Device IDK211344
510k NumberK211344
Device Name:MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, And GALAXY G3 Mini Microcoil Delivery Systems
ClassificationDevice, Neurovascular Embolization
Applicant Medos International SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactAriell Joiner
CorrespondentAriell Joiner
CERENOVUS 6303 Blue Lagoon Drive, Suite 315 Miami,  FL  33126
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-05-28

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.