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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade Name Selective Cytopheretic Device (SCD-PED)
Classification Namepediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury
Generic Namepediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury
Applicant
SeaStar Medical
3513 brighton boulevard
denver, CO 80216
HDE NumberBH220740
Date Received07/13/2022
Decision Date02/21/2024
Product Code
QZV[ Registered Establishments with QZV ]
Advisory Committee Hematology
Expedited Review Granted? No
Combination ProductNo
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