Device Classification Name |
Device, Vascular, For Promoting Embolization
|
510(k) Number |
K200083 |
Device Name |
EMBA Hourglass Peripheral Embolization Device (PED) |
Applicant |
Embolic Acceleration, LLC |
3451 Commerce Pkwy |
Miramar,
FL
33025
|
|
Applicant Contact |
Veronica McDougall |
Correspondent |
Embolic Acceleration, LLC |
3451 Commerce Pkwy |
Miramar,
FL
33025
|
|
Correspondent Contact |
Veronica McDougall |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 01/15/2020 |
Decision Date | 02/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|