QHW

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Single Lumen Ecmo Cannula

Device class

Class II (moderate risk)

Regulation

21 CFR 870.4100

Medical specialty

Cardiovascular

FDA 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.

Adverse events (MAUDE)

2024: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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