Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1287243

FEI Number

1287243

Entity Name

CardioRenal Systems, Inc.

City/State/Country

Milford, MA, US

Establishment Address

459 FORTUNE BLVD, Milford, MA 01757, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

CardioRenal Systems, Inc. (Owner Number: 1287243)

Owner / Operator Contact Address

459 FORTUNE BLVD, --, Milford, MA 01757, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDR	Controller, Infusion, Intravascular, Electronic	General Hospital	Class 2	880.5725	2016-03-25

Official Correspondent

Richard Yeomans

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CardioRenal Systems, Inc.

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 1287243. Last updated year: 2026. Please use registration number 1287243 when referencing this establishment in official correspondence.