OCS Heart Leukocyte Depleting Filter— 510(k) K231362

Substantially Equivalent

TransMedics, Inc.

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

Clearance details

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

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