SEASTAR MEDICAL, INC.

FDA Device Registration & Listing · Denver, CO, US · Registration 3015045325

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015045325
FEI Number
3015045325
Entity Name
SEASTAR MEDICAL, INC.
City/State/Country
Denver, CO, US
Establishment Address
3513 Brighton Blvd., Suite 410, Denver, CO 80216, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
SeaStar Medical, Inc. (Owner Number: 10058906)
Owner / Operator Contact Address
3513 Brighton Blvd, Suite 410, Denver, CO 80216, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

QUELIMMUNE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QZV Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury Unknown Class 3 N/A 2024-04-30

Official Correspondent

Emily Scribe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SeaStar Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015045325. Last updated year: 2026. Please use registration number 3015045325 when referencing this establishment in official correspondence.
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