Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011142981

FEI Number

3011142981

Entity Name

Rontis Hellas S.A.

City/State/Country

Larisa Thessalia, GR

Establishment Address

Industrial Area of Larisa, Larisa Thessalia 41500, GR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rontis Hellas SA (Owner Number: 10050943)

Owner / Operator Contact Address

Industrial Area of Larissa, Larissa, GR-E 40006, GR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190037

PMA Number

N/A

All Registered Proprietary Names

Cronus

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	2019-11-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-11-06

Official Correspondent

Irene Tsaliki

US Agent Details

JESSICA OSWALD-MCLEOD Business: NIPRO MEDICAL CORPORATION Email: JessicaO@nipromed.com Phone: (305) 4326699

Related Public Records

Same Entity

Rontis Hellas SA

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
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
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
9681260	Boston Scientific Limited	GALWAY, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011142981. Last updated year: 2026. Please use registration number 3011142981 when referencing this establishment in official correspondence.