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FDA 510(k)

OCS Heart Leukocyte Depleting Filter

K-Number: K231362 · 2023-10-31

ApplicantTransMedics, Inc.
Decision Date2023-10-31
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCS Heart Leukocyte Depleting Filter is a medical device manufactured by TransMedics, Inc.. It received FDA 510(k) clearance on 2023-10-31 under approval number K231362. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCS Heart Leukocyte Depleting Filter?

OCS Heart Leukocyte Depleting Filter is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by TransMedics, Inc.. The 510(k) number is K231362.

When was OCS Heart Leukocyte Depleting Filter approved by the FDA?

OCS Heart Leukocyte Depleting Filter received FDA 510(k) clearance on 2023-10-31, under approval number K231362.

What company makes OCS Heart Leukocyte Depleting Filter?

OCS Heart Leukocyte Depleting Filter is manufactured by TransMedics, Inc..

What is the FDA product code for OCS Heart Leukocyte Depleting Filter?

The FDA product code for OCS Heart Leukocyte Depleting Filter is DTM.

Related Clinical Trials

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Other Devices by TransMedics, Inc.

K211314OCS Lung Solution K222535OCS Lung Donor Flush Set PMA P160013Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation PMA P200031Normothermic machine perfusion system for the preservation of donor livers prior to transplantation PMA P180051Organ care system (OCS) heart system

Related Devices (Code: DTM)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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