Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OCS Lung Solution

K-Number: K211314 · 2021-07-29

ApplicantTransMedics, Inc.
Decision Date2021-07-29
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OCS Lung Solution is the device name listed in this FDA 510(k) record. The listed applicant is TransMedics, Inc.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) 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. The listed applicant is TransMedics, Inc.. The 510(k) number is K211314.

When did OCS Lung Solution receive FDA 510(k) clearance?

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

Who is the listed applicant for OCS Lung Solution?

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 Lung Solution?

The FDA product code for OCS Lung Solution is MSB.

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 systemK231362OCS Heart Leukocyte Depleting FilterK222535OCS Lung Donor Flush Set

Related Devices (Code: MSB)

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.

K222535OCS Lung Donor Flush SetTransMedics, Inc.K190063Servator C SALF SolutionS.A.L.F. SpaK182735Paragonix SherpaPak Cardiac Transport SystemParagonix TechnologiesK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, 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.

↑