BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN

    K Number: K132567 · Decision Nov 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    130
    Review Days
    82

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
    K Number
    K132567
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien
    Date Received
    August 15, 2013
    Decision Date
    November 5, 2013
    Product Code
    LJS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LJS), ordered by most recent decision date.

    Neonav ECG Tip Location System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PM2™ System with ECGuide™ Connector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PM2+ System and SmartPICC Stylet

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Covidien

    K Number Device Name
    K241486 Sofsilk™ Coated Braided Silk Suture
    K240077 Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
    K231934 GIA™ Stapler with Tri-Staple™ Technology
    K231240 MaxTack™ Motorized Fixation Device
    K223130 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
    K232126 EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
    K231491 TA™ Stapler and Loading Unit with DST Series™ Technology
    K221629 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
    K221771 EEA Circular Stapler with Tri-Staple Technology
    K222641 Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
    Search all 130 clearances from Covidien →