Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007029079

FEI Number

3007029079

Entity Name

AMPHENOL ALDEN PRODUCTS COMPANY

City/State/Country

Hermosillo Sonora, MX

Establishment Address

Parque Industrial Dynatech, Ave. Severiano Talamante No. 6-B, Hermosillo Sonora 83170, MX

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

XL+ CBL External Paddle Assy XL+ MECHASY Adapter Paddle Hybrid Electr Da Vinci Monopolar and Bipolar Adapters System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy CABLE, ELECTRODE Pulse Lok Internal Paddle Adapter Cable Assembly INTELLANAV Cable Electrophysiology Cable Sterile Cable Cable, IntellaTip MiFi XP IZDS CONNECTING CABLE Rhythmia HDx 6m Clearsign Direct Connect Orion Rhythmia HDx 3m CardioLab Direct Connect ECG Rhytmia HDx 3m Clearsign Direct Connect ECG Rhythmia HDx Patch Cable Rhythmia HDx 3m Clearsign Direct Connect IC A/B Rhythmia HDx Breakout Box Cable Rhythmia HDx 6m CardioLab Direct Connect IC Rhymia HDx 6m Clearsign Direct Connect ECG Rhytmia HDx 3m Clearsign Direct Connect Orion Rhythmia HDx 6m Clearsign Direct Connect IC A/B Rhythmia HDX 3m CardioLab Direct Connect IC EGM Out to SIgnal Station Cable -Stockert Rhythimia HDx 6m CardioLab Direct Connect ECG EGM Out to Signal Station Cable -IBI IZDS CONNECTING CABLE EnergyShield Monopolar Cautery Cord INTELLANAV Cable Electrophysiology Cable Sterile Cable CABLE SIMPLICITY III TO COSMAN RFG Codman Electrosurgical Interconnecting Cable LABSYSTEM PRO, CLEARSIGN Amplifier to CARTO 3 System Quick Connect Intracardiac Cable LABSYSTEM PRO, 40-Channel IC Junction Box for CLEARSIGN Amplifier LABSYSTEM PRO, RF Filter Module for CLEARSIGN Amplifier LABSYSTEM PRO, Stimulator Cable for CLEARSIGN Amplifier Pulse Lok Heartstream Pads Adapter Cable Assy MRx CBL Therapy Receptacle II 3ED MRx CBL Pads With CPR Assist Agilent Pads Adapter Supplier Assy FARASTAR Catheter Connection Cable FARASTAR Gen 2 Catheter Connection Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2021-03-30
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2021-03-30
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2021-03-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-22
MEQ	System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy	Unknown	Class 3	N/A	2022-12-08
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2016-12-20
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2008-04-24
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2021-03-30
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
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2025-11-24
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2025-11-24
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-03-28
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2015-07-30
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-05-11
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2024-05-03
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2019-09-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-12-10
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2020-01-23
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2008-04-24
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2021-03-30
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2021-03-30
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-03-30
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	Class 2	870.5210	2021-03-30
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2021-03-30
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2021-03-30
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-02-01

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
3012260771	AMPHENOL ALDEN PRODUCTS COMPANY	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K203231	Philips North America, LLC	Switched Internal Paddles	2021-01-11
K200849	Remote Diagnostic Technologies, Ltd. A Philips Company	Tempus LS - Manual	2020-07-24
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Similar Registrations

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3010030355	PHYSIO-CONTROL MAASTRICHT, INC.	Maastricht Limburg, NL
3029871637	ZOLL International Holding B.V.	Elst Gelderland, NL
3015876	PHYSIO-CONTROL, INC.	Redmond, WA, US
3017422354	EMI (DONGGUAN) ASIA LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007029079. Last updated year: 2026. Please use registration number 3007029079 when referencing this establishment in official correspondence.