Device Classification Name |
device, vascular, for promoting embolization
|
510(k) Number |
K213200 |
Device Name |
Solus Gold Embolization Device |
Applicant |
Artio Medical, Inc. |
127 Independence Drive |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Erdie De Peralta |
Correspondent |
Artio Medical, Inc. |
127 Independence Drive |
Menlo Park,
CA
94025
|
|
Correspondent Contact |
Erdie De Peralta |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 09/29/2021 |
Decision Date | 03/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|