FDA 510(k)

OCS Lung Solution

K-Number: K211314 · 2021-07-29

Decision Date2021-07-29

Product CodeMSB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OCS Lung Solution is a medical device manufactured by TransMedics, Inc.. It received FDA 510(k) clearance on 2021-07-29 under approval number K211314. 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 Solution?

OCS Lung Solution is a medical device that received FDA 510(k) clearance on 2021-07-29. It is manufactured by TransMedics, Inc.. The 510(k) number is K211314.

When was OCS Lung Solution approved by the FDA?

OCS Lung Solution received FDA 510(k) clearance on 2021-07-29, under approval number K211314.

What company makes OCS Lung Solution?

OCS Lung Solution is manufactured by TransMedics, Inc..

What is the FDA product code for OCS Lung Solution?

The FDA product code for OCS Lung Solution is MSB.

Other Devices by TransMedics, Inc.

K222535OCS Lung Donor Flush Set 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 K222535OCS Lung Donor Flush SetTransMedics, Inc.

Official Source

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