Cleared Traditional

Novalung ultimate kit (US)

K232926 · Fresenius Medical Care Renal Therapies Group, LLC · Cardiovascular
Apr 2024
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K232926 is an FDA 510(k) clearance for the Novalung ultimate kit (US), 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 April 15, 2024, 208 days after receiving the submission on September 20, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number K232926 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date April 15, 2024
Days to Decision 208 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.