DeviceClearance

Product code QJZ— Cardiovascular

Novalung System

Classification name
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Device class
Class 2
Regulation
21 CFR 870.4100
Advisory panel
Cardiovascular
Total cleared
4
First cleared
Most recent

FDA classification definition

“Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.”

— U.S. Food and Drug Administration, device classification record for product code QJZ under 21 CFR 870.4100, via openFDA

Market context for product code QJZ

FDA has cleared 4 devices under product code QJZ between 2020 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJZ

Adverse events under product code QJZ

product code QJZ
Death
22
Total
22

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QJZ

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