Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005255160

FEI Number

3005255160

Entity Name

ARROTEK MEDICAL LTD

City/State/Country

Co. Sligo Connaught, IE

Establishment Address

Finisklin Business Park, Co. Sligo Connaught N/A, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Arrotek Medical Ltd (Owner Number: 10033099)

Owner / Operator Contact Address

Finisklin Business Park, Co. Sligo, IE-C F91 RR99, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TUBE, TYMPANOSTOMY LiquID 051 6F LP Guide Catheter Extension Neuescue Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2025-06-16
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2024-07-31
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-09-08
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2023-02-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-02-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-02-20

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Arrotek Medical Ltd

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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005255160. Last updated year: 2026. Please use registration number 3005255160 when referencing this establishment in official correspondence.