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U.S. Department of Health and Human Services

Product Classification
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Device tubing, long term support greater than 6 hours
Regulation Description Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Definition The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.
Physical State tubing, connectors
Technical Method the tubing connects other devices in the ECMo circuit and allows blood to pass between them
Target Area heart and lungs
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQWF
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
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? Yes
Third Party Review Not Third Party Eligible
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