Device Classification Name |
Peripheral Mechanical Thrombectomy With Aspiration
|
510(k) Number |
K210190 |
Device Name |
ClotTriever Thrombectomy System |
Applicant |
Irani Medical, Inc. |
9 Parker, Suite 100 |
Irvine,
CA
92618
|
|
Applicant Contact |
Larry Boucher |
Correspondent |
Irani Medical, Inc. |
9 Parker, Suite 100 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Larry Boucher |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 01/25/2021 |
Decision Date | 02/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Clinical Trials |
NCT03575364
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|