Bendit2.7 Steerable Microcatheter

Catheter, Continuous Flush

Bend It Technologies Ltd.

The following data is part of a premarket notification filed by Bend It Technologies Ltd. with the FDA for Bendit2.7 Steerable Microcatheter.

Pre-market Notification Details

Device IDK200582
510k NumberK200582
Device Name:Bendit2.7 Steerable Microcatheter
ClassificationCatheter, Continuous Flush
Applicant Bend It Technologies Ltd. 25 Basel Street Petach Tikva,  IL 4951038
ContactSimona Beilin-nissan
CorrespondentSheila Hemeon-heyer
Heyer Regulatory Solutions LLC P.O. Box 2151 Amherst,  MA  01004 -2151
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-06
Decision Date2020-06-25

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