inforMED
QHWClass II

Single Lumen Ecmo Cannula

Cardiovascular · 21 CFR 870.4100

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.

MDR events38All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances3All time

Event type breakdown

Malfunction35
Injury3

Recalls

0 recall events for this product code

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No recalls on file for this product code.