Drakon And Sequre Microcatheters

Catheter, Intravascular, Diagnostic

Accurate Medical Therapeutics Ltd.

The following data is part of a premarket notification filed by Accurate Medical Therapeutics Ltd. with the FDA for Drakon And Sequre Microcatheters.

Pre-market Notification Details

Device IDK202797
510k NumberK202797
Device Name:Drakon And Sequre Microcatheters
ClassificationCatheter, Intravascular, Diagnostic
Applicant Accurate Medical Therapeutics Ltd. 19 Eli Hurvitz Street Rehovot,  IL 7608802
ContactOsnat Harbater
CorrespondentOsnat Harbater
Accurate Medical Therapeutics Ltd. 19 Eli Hurvitz Street Rehovot,  IL 7608802
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-23
Decision Date2020-10-23

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.