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

    FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER

    K Number: K130507 · Decision Jun 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    4
    Review Days
    96

    Basic Information

    Device Name
    FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
    K Number
    K130507
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Footprint Medical, Inc.
    Date Received
    February 27, 2013
    Decision Date
    June 3, 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 Footprint Medical, Inc.

    K Number Device Name
    K120304 FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
    K102548 FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE
    K093252 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER