Product code QHW

Device name

Single 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

Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure 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