Product code PZS

Device name

Dual Lumen Ecmo Cannula

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.4100

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Source

FDA openFDA device classification dataset