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FDA 510(k)

OCS Lung Donor Flush Set

K-Number: K222535 · 2022-11-18

ApplicantTransMedics, Inc.
Decision Date2022-11-18
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OCS Lung Donor Flush Set is the device name listed in this FDA 510(k) record. The listed applicant is TransMedics, Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) 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. The listed applicant is TransMedics, Inc.. The 510(k) number is K222535.

When did OCS Lung Donor Flush Set receive FDA 510(k) clearance?

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

Who is the listed applicant for OCS Lung Donor Flush Set?

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 Donor Flush Set?

The FDA product code for OCS Lung Donor Flush Set 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 FilterK211314OCS Lung Solution

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.

K211314OCS Lung SolutionTransMedics, 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

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

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