Product code QJZ

Device name

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.4100

Review panel

CV

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset