Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008822486

FEI Number

3008822486

Entity Name

Delcath Systems, Inc.

City/State/Country

Queensbury, NY, US

Establishment Address

566 Queensbury Ave, Queensbury, NY 12804, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Delcath Systems, Inc. (Owner Number: 10036454)

Owner / Operator Contact Address

Delcath Systems, 566 Queensbury Avenue, Queensbury, NY 12804, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CHEMOSAT Hepatic Delivery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLD	Apparatus, Hemoperfusion, Sorbent	Gastroenterology, Urology	Class 2	876.5870	2011-05-09

Official Correspondent

Scott Kiggins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Delcath Systems, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030956240	Delcath Systems, Inc.	Queensbury, NY, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008822486. Last updated year: 2026. Please use registration number 3008822486 when referencing this establishment in official correspondence.