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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K203842
Device Name Bendit21 Microcatheter
Applicant
Bend It Technologies Ltd
25 Basel Street
Petach Tikva,  IL 4951038
Applicant Contact Simona Beilin-Nissan
Correspondent
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received12/31/2020
Decision Date 04/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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