QHW — Single Lumen Ecmo Cannula Class II

FDA Device Classification

Classification Details

Product Code
QHW
Device Class
Class II
Regulation Number
870.4100
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251831medtronicBio-Medicus Life Support Catheter and IntroducerJanuary 15, 2026
K240534medtronicBio-Medicus Life Support Catheter and IntroducerApril 19, 2024
K201057medtronicBio-Medicus Life Support Catheter and IntroducerJanuary 14, 2022