Cleared Traditional

Aventus Clot Management System

K240426 · Inquis Medical · Cardiovascular
May 2024
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K240426 is an FDA 510(k) clearance for the Aventus Clot Management System, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Inquis Medical (Menlo Park, US). The FDA issued a Cleared decision on May 14, 2024, 91 days after receiving the submission on February 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K240426 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2024
Decision Date May 14, 2024
Days to Decision 91 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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