Device Classification Name |
introducer, catheter
|
510(k) Number |
K192106 |
Device Name |
AcQRef Introducer Sheath |
Applicant |
Acutus Medical, Inc. |
2210 Faraday Ave., Suite 100 |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Serena Sanginthirath |
Correspondent |
Acutus Medical, Inc. |
2210 Faraday Ave., Suite 100 |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Serena Sanginthirath |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/05/2019 |
Decision Date | 09/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|