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Dual Lumen Ecmo Cannula

FDA product code PZS · 4 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
2017-11-16 – 2023-10-06

Long term support greater than 6 hours for acute respiratory 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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