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 Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/31/2020 |
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
|
|
|