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Single Lumen Ecmo Cannula

FDA product code QHW · 3 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.4100
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-01-14 – 2026-01-15

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.

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