PARAGONIX TECHNOLOGIES, INC.

FDA Device Registration & Listing · Waltham, MA, US · Registration 3011175555

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
3011175555
FEI Number
3011175555
Entity Name
PARAGONIX TECHNOLOGIES, INC.
City/State/Country
Waltham, MA, US
Establishment Address
950 Winter Street, North, Waltham, MA 02451, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Paragonix Technologies (Owner Number: 10057453)
Owner / Operator Contact Address
950 Winter Street, North, Waltham, MA 02451, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K234060
PMA Number
N/A

All Registered Proprietary Names

SherpaPak™ LIVERguard SherpaPak™ LUNGguard PancreasPak Organ Preservation System BAROguard KidneyVault

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2020-11-18
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2020-01-23
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2023-09-05
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2024-11-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K013575 Organ Recovery Systems, Inc. KPS-I, THE KIDNEY PERFUSION SOLUTION 2002-01-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011175555. Last updated year: 2026. Please use registration number 3011175555 when referencing this establishment in official correspondence.
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