Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030956240

FEI Number

3030956240

Entity Name

Delcath Systems, Inc.

City/State/Country

Queensbury, NY, US

Establishment Address

2 Country Club Road, 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
3008822486	Delcath Systems, Inc.	Queensbury, NY, US

Similar Registrations

Registration Number	Establishment Name	Location
3032828299	VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE LIMITED	Bangalore Karnataka, IN
3011228909	CYTOSORBENTS, INC.	Princeton, NJ, US
3006174295	STERLAB	SIGNES Var, FR
1319660	ISOMEDIX OPERATIONS INC.	CHESTER, NY, US
3008822486	Delcath Systems, Inc.	Queensbury, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030956240. Last updated year: 2026. Please use registration number 3030956240 when referencing this establishment in official correspondence.