510(k) K231782

FlowSaver Blood Return System (80-101) by Inari Medical, Inc. — Product Code CAC

K231782 is an FDA 510(k) premarket notification submitted by Inari Medical, Inc. for the device "FlowSaver Blood Return System (80-101)". The FDA issued a decision of Substantially Equivalent on July 14, 2023. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Inari Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2023
Date Received
June 16, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type