OCS Heart Leukocyte Depleting Filter— 510(k) K231362

Name: FDA 510(k) clearance K231362
Creator: U.S. Food and Drug Administration
Published: 2023-10-31

Substantially Equivalent

TransMedics, Inc.

FDA 510(k) clearance K231362 for OCS Heart Leukocyte Depleting Filter, Substantially Equivalent on 2023-10-31. Applicant: TransMedics, Inc.. Device class: 2.

Clearance details

Applicant: TransMedics, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2023-05-11
Decision date: 2023-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.