Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1282497

FEI Number

1282497

Entity Name

Covidien LLC

City/State/Country

MANSFIELD, MA, US

Establishment Address

15 HAMPSHIRE STREET, MANSFIELD, MA 02048, US

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

K953289

PMA Number

N/A

All Registered Proprietary Names

MAHURKAR Elite Acute Dual Lumen Catheters, Kits, and Trays MAHURKAR Elite Acute Triple Lumen Catheters, Kits, and Trays Permcath Chronic Silicone Oval Catheter Permcath Chronic Silicone Oval Catheter Kits Permcath Pediatric Chronic Silicone Oval Catheter Kit Ritus Argyle Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Stencil Argyle Pediatric Peritoneal Dialysis Catheter Argyle Neonatal Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Kit MODIFIED USE OF PULL-APART INTRODUCER SET Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender Argyle Peritoneal Dialysis Catheter And Kits Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter Argyle Presternal Peritoneal Dialysis Catheter And Kits Tandem-Cath Chronic Dual Catheter System Repair Kit Permcath Pediatric Dual Lumen Catheter Repair Kit Permcath Chronic Silicone Oval Catheter Repair Kit Acute and Chronic Catheter Repair Kit Ritus Peritoneal Dialysis Catheter Tunneling Device and Plug MAHURKAR Acute Triple Lumen Catheter, Kits, and Trays Chameleon PTA Balloon Catheter with Injection Port TUNNELING STYLET Permcath Chronic Silicone Oval Catheter Trays Permcath Pediatric Chronic Silicone Oval Catheter Tray Argyle Acute Single Lumen Catheters and Kits Mahurkar Safety Insertion Tray Argyle Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Stencil Argyle Pediatric Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Kit Argyle Neonatal Peritoneal Dialysis Catheter Palindrome Precision Chronic Catheter Kits and Sport Packs Palindrome Precision SI Chronic Catheter Kits and Sport Packs Palindrome Precision HSI Chronic Catheter Kits and Sport Packs Palindrome Precision H Chronic Catheter Kits and Sport Packs Palindrome Precision RT Chronic Catheter Kits Palindrome RT Chronic Catheter Kit Argyle Palindrome RT Repair Kit Permcath Chronic Silicone Oval Catheter Argyle Peritoneal Dialysis Accessory Argyle Peritoneal Dialysis Accessories MAHURKAR Acute High Pressure Triple Lumen Catheter, Kits, and Trays Permcath Chronic Silicone Oval Catheter Argyle Dialysis Catheter Accessories Argyle Peritoneal Dialysis Accessory MAHURKAR Acute Dual Lumen High Flow Catheter Kits and Trays Argyle Peritoneal Dialysis Accessory Pledgets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-11-14
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-11-14
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2008-01-17
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2008-01-17
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2008-01-16
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2008-01-17
FKO	Catheter, Peritoneal Dialysis, Single Use	Gastroenterology, Urology	Class 2	876.5630	2014-06-30
FKO	Catheter, Peritoneal Dialysis, Single Use	Gastroenterology, Urology	Class 2	876.5630	2018-07-31
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2018-07-31
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-01-16
KNZ	Accessories, A-V Shunt	Gastroenterology, Urology	Class 2	876.5540	2008-01-16
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2009-12-21
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2022-01-14
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-03-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2022-09-12
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2008-01-17
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2014-04-16
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-01-17
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2018-12-05
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2008-01-17
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-02-06
NYU	Catheter, Hemodialysis, Implanted, Coated	Gastroenterology, Urology	Class 2	876.5540	2013-02-06
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-03-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-01-17
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2010-08-11
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2010-08-11
FIQ	Cannula, A-V Shunt	Gastroenterology, Urology	Class 2	876.5540	2008-01-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-01-17
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2008-01-16
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-09-27
FIQ	Cannula, A-V Shunt	Gastroenterology, Urology	Class 2	876.5540	2008-01-16
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-01-17
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2008-01-17
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2008-01-16
FKO	Catheter, Peritoneal Dialysis, Single Use	Gastroenterology, Urology	Class 2	876.5630	2008-01-17
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2003-08-11

Official Correspondent

Marsha Seetaram

US Agent Details

No US Agent registered (Local establishment).

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
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
9681384	Covidien	Ciudad Juarez Chihuahua, MX
2024500	COVIDIEN	CARLSBAD, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171618	Medcomp (Dba Medical Components, Inc.)	Symetrex Long Term Hemodialysis Catheter	2017-11-16
K111817	Covidien	PALINDROME RT CHRONIC CATHETER	2011-08-30
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0018-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0043-2015	Covidien LLC	2	Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
Z-0044-2015	Covidien LLC	2	Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
Z-0045-2015	Covidien LLC	2	Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
Z-0046-2015	Covidien LLC	3	Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
Z-0047-2015	Covidien LLC	3	MediChoice Multifunction Electrode Part Number: MC171 OH
Z-0048-2015	Covidien LLC	2	Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
Z-0070-2019	COVIDIEN LLC	2	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Z-0339-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A3ENNISB
Z-0340-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Z-0341-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Z-0342-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Z-0343-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Z-0344-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
Z-0345-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator,980X1ENAIQC
Z-0346-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Z-0347-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Z-0348-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Z-0349-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
Z-0350-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
Z-0351-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Z-0352-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Z-0353-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Similar Registrations

Registration Number	Establishment Name	Location
3006082230	C.R. BARD, INC.	MADISON, GA, US
1319639	Sterigenics U.S., LLC	Queensbury, NY, US
2030624	Isomedix Operations, Inc.	Temecula, CA, US
3003915875	MARTECH MEDICAL PRODUCTS S. DE RL. DE CV.	MEXICALI Baja California, MX
9617592	BARD REYNOSA S.A. DE C.V.	REYNOSA Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1282497. Last updated year: 2026. Please use registration number 1282497 when referencing this establishment in official correspondence.