Cleared Traditional

INSPIRA ART100

K232788 · Inspira Technologies Oxy B.H.N. , Ltd. · Cardiovascular
May 2024
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K232788 is an FDA 510(k) clearance for the INSPIRA ART100, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Inspira Technologies Oxy B.H.N. , Ltd. (Ra?Anana, IL). The FDA issued a Cleared decision on May 24, 2024, 256 days after receiving the submission on September 11, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K232788 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2023
Decision Date May 24, 2024
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWA — Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4380

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