Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004415014

FEI Number

3004415014

Entity Name

NATEC MEDICAL LTD

City/State/Country

Moka, MU

Establishment Address

Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cote DOr, Moka 80829, MU

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NATEC MEDICAL LTD (Owner Number: 9060577)

Owner / Operator Contact Address

Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cote DOr, Moka, MU-NOTA 80829, MU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142459

PMA Number

N/A

All Registered Proprietary Names

Amethyst HP PTA OTW 035" Catheter EBONY 14" PTA catheters USE014 Ebony 014" PTA Rx Catheter Ebony PTA 035OTW USE 035 Amethyst HP PTA OTW 035 Amethyst HP PTA OTW 035" Catheter USE014 EBONY 14'' PTA Catheters USE 014/018otw Ebony PTA 014/018 OTW Ebony 014" PTA OTW Catheter, Ebony 018" PTA OTW Catheter, Victory 014" & 018" PTA OTW Catheter FILAO NC Filao NC RX PTCA Dilatation Catheter Tamarin Blue PTCA Rx Dilatation Catheter USE014 RX Ebony PTA014RX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2026-01-20
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2016-01-14
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-04-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2025-02-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-03-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-03-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-06-19
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2016-01-14
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2021-08-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-02-12

Official Correspondent

VINCENT LAGARDE

US Agent Details

Semih Oktay H. Semih Oktay Business: CardioMed Device Consultants, LLC Email: soktay@cardiomedllc.com Phone: (410) 6742060

Related Public Records

Same Entity

NATEC MEDICAL LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006550224	NATEC MEDICAL LTD (Maurister)	BAMBOUS Riviere du Rempart, MU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter	2026-02-13
K142654	Covidien, LLC	Fortrex 0.035 OTW PTA Balloon Catheter	2014-10-28
K202800	Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)	Pacific Plus PTA Catheter	2020-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
1018233	C.R. BARD, INC.	COVINGTON, GA, US
3010273872	Synergy Health AST, SRL	Alajuela, CR
1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US
3005994106	Creagh Medical Ltd.	Co. Galway, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004415014. Last updated year: 2026. Please use registration number 3004415014 when referencing this establishment in official correspondence.