OCS Lung Solution— 510(k) K211314

Substantially Equivalent

TransMedics, Inc.

FDA 510(k) clearance K211314 for OCS Lung Solution, Substantially Equivalent on 2021-07-29. 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: 2021-04-30
Decision date: 2021-07-29
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.