Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K180653 |
Device Name |
Spartan eCoil System |
Applicant |
Spartan Micro, Inc |
3167 Skyway Court |
Freemont,
CA
94539
|
|
Applicant Contact |
Mark Dias |
Correspondent |
Ambriel Associates, Inc. |
411 Walnut St. Unit 9236 |
Green Cove Springs,
FL
32043
|
|
Correspondent Contact |
Vikki M. O'Connor |
Regulation Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/13/2018 |
Decision Date | 12/04/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|