Device Classification Name |
peripheral mechanical thrombectomy with aspiration
|
510(k) Number |
K191710 |
Device Name |
FlowTriever Retrieval/Aspiration System |
Applicant |
Inari Medical |
9272 Jeronimo Rd., Suite 124 |
Irvine,
CA
92618
|
|
Applicant Contact |
Eben Gordon |
Correspondent |
Inari Medical |
9272 Jeronimo Rd., Suite 124 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Eben Gordon |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2019 |
Decision Date | 09/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|