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U.S. Department of Health and Human Services

Product Classification

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Device dual lumen ecmo cannula
Regulation Description Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Definition 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.
Physical State The device consists of a catheter with dual lumens. Holes in the outer and inner lumens allow for ingress and egress of blood.
Technical Method The device is inserted into the vasculature and connected to other devices in the ECMO circuit to allow for drainage and reinfusion of blood during ECMO procedures.
Target Area The device is inserted into the vasculature and connected to the extracorporeal circuit to allow for circulation of blood.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePZS
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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