Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K192122 |
Device Name |
Trevo Trak 21 Microcatheter |
Applicant |
Stryker |
47900 Bayside Parkway |
Fremont,
CA
94538
|
|
Applicant Contact |
Rhoda Santos |
Correspondent |
Stryker |
47900 Bayside Parkway |
Fremont,
CA
94538
|
|
Correspondent Contact |
Rhoda Santos |
Regulation Number | 870.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/06/2019 |
Decision Date | 11/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|