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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 K252213
Device Name Bendit17 Microcatheter
Applicant
Bend IT Technologies, Ltd.
25 Basel St.
Petach Tikva,  IL 4951038
Applicant Contact Simona Beilin Nissan
Correspondent
Heyer Regulatory Solutions
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received07/15/2025
Decision Date 12/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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