Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K231782 |
Device Name |
FlowSaver Blood Return System (80-101) |
Applicant |
Inari Medical, Inc. |
6001 Oak Canyon, Suite 100 |
Irvine,
CA
92618
|
|
Applicant Contact |
Kaitlyn Weinkauf |
Correspondent |
Inari Medical, Inc. |
6001 Oak Canyon, Suite 100 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Kaitlyn Weinkauf |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 06/16/2023 |
Decision Date | 07/14/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|