Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K161429 |
Device Name |
Target Detachable Coils |
Applicant |
Stryker Neurovascular |
47900 Bayside Parkway |
Fremont,
CA
94538 -2588
|
|
Applicant Contact |
Kate Taylor |
Correspondent |
Stryker Neurovascular |
47900 Bayside Parkway |
Fremont,
CA
94538 -2588
|
|
Correspondent Contact |
Kate Taylor |
Regulation Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2016 |
Decision Date | 06/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|