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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 the device name listed in this FDA 510(k) record. The listed applicant is TransMedics, Inc.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) 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. The listed applicant is TransMedics, Inc.. The 510(k) number is K231362.

When did OCS Heart Leukocyte Depleting Filter receive FDA 510(k) clearance?

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

Who is the listed applicant for OCS Heart Leukocyte Depleting Filter?

The FDA 510(k) record lists TransMedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing TransMedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P200031Normothermic machine perfusion system for the preservation of donor livers prior to transplantationPMA P160013Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantationPMA P180051Organ care system (OCS) heart systemK222535OCS Lung Donor Flush SetK211314OCS Lung Solution

Related Devices (Code: DTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.

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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