Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K182487 |
Device Name |
CerusEndo Microcatheter |
Applicant |
Cerus Endovascular, Inc. |
47757 Fremont Boulevard |
Fremont,
CA
94538
|
|
Applicant Contact |
Theresa Brandner |
Correspondent |
Cerus Endovascular, Inc. |
47757 Fremont Boulevard |
Fremont,
CA
94538
|
|
Correspondent Contact |
Theresa Brandner |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/11/2018 |
Decision Date | 07/20/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|