Cleared Traditional

Novalung System

K191407 · Fresenius Medical Care Renal Therapies Group, LLC · Cardiovascular
Feb 2020
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K191407 is an FDA 510(k) clearance for the Novalung System, a Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure (Class II — Special Controls, product code QJZ), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on February 21, 2020, 269 days after receiving the submission on May 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number K191407 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2019
Decision Date February 21, 2020
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QJZ — Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4100
Definition Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure.