Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020889

FEI Number

3003382061

Entity Name

Mallinckrodt Medical

City/State/Country

ATHLONE Westmeath, IE

Establishment Address

CORNAMADDY, ATHLONE Westmeath --, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K962173

PMA Number

N/A

All Registered Proprietary Names

Shiley Extended XLT BronchoCath with CPAP Shiley STYLET, TRACHEAL TUBE Shiley Adult Flexible EVAC Tracheostomy Tube with TaperGuard Cuff SealGuard Evac Tracheal Tubes SealGuard Tracheal Tubes BronchoCath Shiley Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115- XXOR) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119- XXNR) Tube, tracheal Infusion Catheter Cragg-McNamara Valved Infusion Catheter Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Safety Flex Shiley Adult Trach. Tubes & Access.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-02-01
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2008-02-01
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2008-02-27
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2020-06-01
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2020-06-01
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-10-28
BTS	Tube, Bronchial (W/Wo Connector)	Anesthesiology	Class 2	868.5720	2008-02-01
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2026-04-17
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-02-01
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-11-10
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2026-04-20
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-02-01
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

Kae Miller Business: Medtronic formerly Covidien Email: kae.miller@medtronic.com Phone: (303) 4081427

Related Public Records

Same Entity

Covidien llc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX
2024500	COVIDIEN	CARLSBAD, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K934685	Mallinckrodt Medical	SOFTTOUCH GUIDE CATHETER	1994-04-07
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22
K142296	Covidien	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	2015-02-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

Similar Registrations

Registration Number	Establishment Name	Location
2936999	Covidien	Lafayette, CO, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB
1824231	ICU Medical, Inc.	Gary, IN, US
3014054118	FOGLESS INTERNATIONAL AB	Vaggeryd Jonkoping, SE
3030626857	PALM MEDICAL INTERNATIONAL BV	Buggenhout Oost-Vlaanderen, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020889. Last updated year: 2026. Please use registration number 8020889 when referencing this establishment in official correspondence.