Cleared Traditional

FlowSaver Blood Return System

K221483 · Inari Medical, Inc. · Cardiovascular
Feb 2023
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K221483 is an FDA 510(k) clearance for the FlowSaver Blood Return System, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 17, 2023, 270 days after receiving the submission on May 23, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K221483 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2022
Decision Date February 17, 2023
Days to Decision 270 days
Submission Type Traditional
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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