FDA 510(k)

OCS Lung Donor Flush Set

K-Number: K222535 · 2022-11-18

Decision Date2022-11-18

Product CodeMSB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OCS Lung Donor Flush Set is a medical device manufactured by TransMedics, Inc.. It received FDA 510(k) clearance on 2022-11-18 under approval number K222535. The device is classified under product code MSB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCS Lung Donor Flush Set?

OCS Lung Donor Flush Set is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by TransMedics, Inc.. The 510(k) number is K222535.

When was OCS Lung Donor Flush Set approved by the FDA?

OCS Lung Donor Flush Set received FDA 510(k) clearance on 2022-11-18, under approval number K222535.

What company makes OCS Lung Donor Flush Set?

OCS Lung Donor Flush Set is manufactured by TransMedics, Inc..

What is the FDA product code for OCS Lung Donor Flush Set?

The FDA product code for OCS Lung Donor Flush Set is MSB.

Other Devices by TransMedics, Inc.

K211314OCS Lung Solution K231362OCS Heart Leukocyte Depleting Filter 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: MSB)

K182735Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. K190063Servator C SALF SolutionS.A.L.F. Spa K211314OCS Lung SolutionTransMedics, Inc.

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.