QJZ

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Product code
QJZ
Device name
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Device class
Class 2
21 CFR
21 CFR 870.4100
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Life-sustaining / life-supporting
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
4 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-07-31.

NumberDecision dateApplicantDevice nameSummary
K2613352026-07-31Medtronic, Inc.VitalFlow Set with Balance™ BiosurfaceFDA
K2408802024-09-12Medtronic, Inc.VitalFlow Set with Balance BiosurfacePDF
K2329262024-04-15Fresenius Medical Care Renal Therapies…Novalung ultimate kit (US)PDF

2 summaries are archived here for direct download.

Official FDA classification page: QJZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).