Device Classification Name |
Catheter, Intracardiac Mapping, High-Density Array
|
510(k) Number |
K210766 |
Device Name |
AcQMap 3D Imaging and Mapping Catheter, Model 900009 |
Applicant |
Acutus Medical, Inc. |
2210 Faraday Ave, Suite 100 |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Karla Schaffner |
Correspondent |
Acutus Medical, Inc. |
2210 Faraday Ave, Suite 100 |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Karla Schaffner |
Regulation Number | 870.1220
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/2021 |
Decision Date | 06/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|