Cleared Special

FlowSaver Blood Return System (80-101)

K231782 · Inari Medical, Inc. · Cardiovascular
Jul 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K231782 is an FDA 510(k) clearance for the FlowSaver Blood Return System (80-101), a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on July 14, 2023, 28 days after receiving the submission on June 16, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K231782 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2023
Decision Date July 14, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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