Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K200582 |
Device Name |
Bendit2.7 Steerable Microcatheter |
Applicant |
Bend It Technologies Ltd. |
25 Basel Street |
Petach Tikva,
IL
4951038
|
|
Applicant Contact |
Simona Beilin-Nissan |
Correspondent |
Heyer Regulatory Solutions LLC |
P.O. Box 2151 |
Amherst,
MA
01004 -2151
|
|
Correspondent Contact |
Sheila Hemeon-Heyer |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 03/06/2020 |
Decision Date | 06/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|