Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009243923

FEI Number

3009243923

Entity Name

Flextronics (Israel) LTD

City/State/Country

Migdal Haemek Northern, IL

Establishment Address

2 Hamatechet Street, Migdal Haemek Northern 2306995, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Flextronics International USA, Inc. (Owner Number: 9006592)

Owner / Operator Contact Address

12455 Research Blvd, Austin, TX 78759, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CELSIUS : CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTO NAVISTAR QDOT Micro Catheter with nGEN Generator nGEN Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2022-04-27
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2019-04-03
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-04-27
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2023-01-11
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-01-11
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2022-04-27

Official Correspondent

Chad Ashton

US Agent Details

Chad Ashton Business: FLEXTRONICS INTERNATIONAL USA, INC. Email: chad.ashton@flex.com Phone: (901) 8712423

Related Public Records

Same Entity

Flextronics International USA, 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
3003027964	Flex Precision Plastics Solutions (Switzerland) AG	Hagglingen Aargau, CH
3008886285	Flextronics International Kft	Budapest, HU
3006126537	FLEXTRONICS INTERNATIONAL GMBH	ALTHOFEN Karnten, AT
3021010223	Flex Precision Plastics Solutions AG	Kussnacht Schwyz, CH
3022473387	Flextronics Medical Molding (Shenzhen) Co., Ltd	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17

Similar Registrations

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1721983	CEA Medical Manufacturing, Inc.	Colorado Springs, CO, US
1000121056	Boston Scientific Corporation	Coventry, RI, US
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
2182269	St. Jude Medical, Atrial Fibrillation Division, Inc.	Minnetonka, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009243923. Last updated year: 2026. Please use registration number 3009243923 when referencing this establishment in official correspondence.