Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012260771

FEI Number

3012260771

Entity Name

AMPHENOL ALDEN PRODUCTS COMPANY

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building 1, No.7, Dongbao Road,, Dongkeng Community, Fenghuang Sub-District, Guangming District, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Amphenol Alden Products Company (Owner Number: 10025614)

Owner / Operator Contact Address

800 Technology Center Drive, Stoughton, MA 02072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Workmate Claris CI Module Computer, Diagnostic, Programmable - IBP Cable Truwave; Worknmate Claris CI Module INTELLANAV Cable Electrophysiology Cable Sterile Cable FARASTAR Catheter Connection Cable FARASTAR Gen 2 Catheter Connection Cable IntellaNav StablePoint Cable INTELLANAV Cable Electrophysiology Cable Sterile Cable Cable, IntellaTip MiFi XP Ensite H700090 Comet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-04-16
DTC	Analyzer, Pacemaker Generator Function	Cardiovascular	Class 2	870.3630	2018-01-31
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2024-05-03
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-02-01
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2024-02-28
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2024-02-28
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2024-05-03
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2024-05-03
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-09-11
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2017-03-10

Official Correspondent

Michael Virusso

US Agent Details

Michael Virusso Business: Amphenol Alden Products Email: mike.virusso@amphenolalden.com Phone: (781) 9531570

Related Public Records

Same Entity

Amphenol Alden Products Company

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007029079	AMPHENOL ALDEN PRODUCTS COMPANY	Hermosillo Sonora, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012260771. Last updated year: 2026. Please use registration number 3012260771 when referencing this establishment in official correspondence.