An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Approved Blood Products

QUELIMMUNE

STN:BH220740
Proper Name: Selective Cytopheretic Device (SCD-PED)
Tradename: QUELIMMUNE
Manufacturer: SeaStar Medical, Inc.

Indication:

The Selective Cytopheretic Device for Pediatrics (SCD-PED) is indicated for treatment of pediatric patients (weight ≥10kg and age ≤22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT).

Product Information

Instructions for Use - QUELIMMUNE

Supporting Documents

Top