Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K210339 |
Device Name |
Bullfrog Micro-Infusion Device |
Applicant |
Mercator MedSystems, Inc. |
1900 Powell Street |
Suite 800 |
Emeryville,
CA
94608
|
|
Applicant Contact |
Kirk P. Seward |
Correspondent |
Mercator MedSystems, Inc. |
1900 Powell Street |
Suite 800 |
Emeryville,
CA
94608
|
|
Correspondent Contact |
Kirk P. Seward |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 02/05/2021 |
Decision Date | 08/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|