Cleared Traditional

OCS Lung Solution

K211314 · TransMedics, Inc. · Gastroenterology & Urology

Jul 2021

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K211314 is an FDA 510(k) clearance for the OCS Lung Solution, a System And Accessories, Isolated Heart, Transport And Preservation (Class II — Special Controls, product code MSB), submitted by TransMedics, Inc. (Andover, US). The FDA issued a Cleared decision on July 29, 2021, 90 days after receiving the submission on April 30, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.

Submission Details

510(k) Number	K211314 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2021
Decision Date	July 29, 2021
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	MSB — System And Accessories, Isolated Heart, Transport And Preservation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5880