GALAXY THERAPEUTICS INC.

FDA Device Registration & Listing · Milpitas, CA, US · Registration 3022418643

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
3022418643
FEI Number
3022418643
Entity Name
GALAXY THERAPEUTICS INC.
City/State/Country
Milpitas, CA, US
Establishment Address
803 Ames Ave, Milpitas, CA 95035, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Galaxy Therapeutics (Owner Number: 10084956)
Owner / Operator Contact Address
803 Ames Avenue, Milpitas, CA 95035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SEAL Embolization System SEAL Detachment Handle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUT Intracranial Aneurysm Flow Diverter Unknown Class 3 N/A 2022-04-20
OPR Intrasaccular Flow Disruption Device Unknown Class 3 N/A 2024-02-08

Official Correspondent

James Twitchell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Galaxy Therapeutics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022418643. Last updated year: 2026. Please use registration number 3022418643 when referencing this establishment in official correspondence.
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