Cleared Traditional

OCS Heart Leukocyte Depleting Filter

K231362 · TransMedics, Inc. · Cardiovascular
Oct 2023
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K231362 is an FDA 510(k) clearance for the OCS Heart Leukocyte Depleting Filter, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by TransMedics, Inc. (Andover, US). The FDA issued a Cleared decision on October 31, 2023, 173 days after receiving the submission on May 11, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.

Submission Details

510(k) Number K231362 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2023
Decision Date October 31, 2023
Days to Decision 173 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4260

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