Device Classification Name |
catheter, thrombus retriever
|
510(k) Number |
K183464 |
Device Name |
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) |
Applicant |
Stryker |
47900 Bayside Parkway |
Fremont,
CA
94538
|
|
Applicant Contact |
Germaine Fu |
Correspondent |
Stryker |
47900 Bayside Parkway |
Fremont,
CA
94538
|
|
Correspondent Contact |
Germaine Fu |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 12/14/2018 |
Decision Date | 03/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|