OCS Lung Donor Flush Set— 510(k) K222535

Substantially Equivalent

TransMedics, Inc.

FDA 510(k) clearance K222535 for OCS Lung Donor Flush Set, Substantially Equivalent on 2022-11-18. Applicant: TransMedics, Inc.. Device class: 2.

Clearance details

Applicant: TransMedics, Inc.
Product code: Code MSB
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2022-08-22
Decision date: 2022-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.