BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Covidien LLC

    Reg #: 1282497 · FEI: 1282497 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    66
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    Covidien LLC
    Registration Number
    1282497
    FEI Number
    1282497
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    15 HAMPSHIRE STREET
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120674

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US
    Correspondent
    Marsha Seetaram

    Products

    Device Name Product Code
    Catheter, Hemodialysis, Non-Implanted MPB
    Catheter, Hemodialysis, Triple Lumen, Non-Implanted NIE
    Catheter, Subclavian LFJ
    Catheter, Peritoneal, Long-Term Indwelling FJS
    Catheter, Peritoneal Dialysis, Single Use FKO
    Catheter, Hemodialysis, Implanted MSD
    Accessories, A-V Shunt KNZ
    Kit, Repair, Catheter, Hemodialysis NFK
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Stylet, Catheter DRB
    Dialysis Administration Kit PEV
    Catheter, Hemodialysis, Implanted, Coated NYU
    Introducer, Catheter DYB
    Cannula, A-V Shunt FIQ
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Wire, Guide, Catheter DQX
    Catheter, Continuous Flush KRA

    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 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 Argyle Peritoneal Dialysis Accessory Argyle Peritoneal Dialysis Accessories MAHURKAR Acute High Pressure Triple Lumen Catheter, Kits, and Trays Argyle Dialysis Catheter Accessories MAHURKAR Acute Dual Lumen High Flow Catheter Kits and Trays Pledgets Argyle Faller Tunneling Trocar breathing circuit Male to male adapter Y PIECE) MAHURKAR Chronic Carbothane Catheter Kit, Trays, and Sport Packs Palindrome Chronic Catheter Kits and Sport Packs Tandem-Cath Chronic Dual Catheter System Palindrome HSI Chronic Catheter Kits and Sport Packs Palindrome H Chronic Catheter Kits and Sport Packs Palindrome SI Chronic Catheter Kits and Sport Packs MAHURKAR Chronic Silicone Catheter Kits and Trays Argyle J/Straight Stainless Steel Guidewire Argyle Presternal Peritoneal Dialysis Catheter Trays Argyle Presternal Peritoneal Dialysis Catheter Kit Argyle Presternal Peritoneal Dialysis Catheter Argyle Adult Peritoneal Dialysis Accessory MAHURKAR Acute Dual Lumen Catheters, Kits, and Trays Mahurkar™ Acute Single Lumen Catheter Straight Extension 8 Fr/Ch (2.7 mm) x 15 cm Mahurkar™ Acute Single Lumen Catheter Straight Extension 8 Fr/Ch (2.7 mm) x 19.5 cm Mahurkar™ Acute Catheter Accessory Y-Adapter Mahurkar™ Acute Single Lumen Catheter Kit Straight Extension 8 Fr/Ch (2.7 mm) x 15 cm Mahurkar™ Acute Single Lumen Catheter Kit Curved Extension 8 Fr/Ch (2.7 mm) x 15 cm Mahurkar™ Acute Single Lumen Catheter Kit Straight Extension8 Fr/Ch (2.7 mm) x 19.5 cm Chameleon PTA Balloon Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device