510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QJZClass II

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

21 CFR 870.4100 / Cardiovascular
FDA source (opens on fda.gov)

QJZ is the FDA product code for Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure, a class II device type, regulated under 21 CFR 870.4100. FDA's definition for this code reads: "Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
QJZ
Device name
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
FDA definition
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
2

Clearances, product code QJZ

By decision year
4 clearances under product code QJZ with a decision year between 2020 and 2026, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QJZ by decision year
YearClearances
20201
20242
20261

Applicants with the most clearances

Product code QJZ
Applicants holding the most 510(k) clearances under product code QJZ
ApplicantClearances
Fresenius Medical Care Renal Therapies Group, LLC2
Medtronic, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code