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

    LIFE VAC #2191 & 2192

    K Number: K831802 · Decision Jan 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    20
    Review Days
    222

    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
    LIFE VAC #2191 & 2192
    K Number
    K831802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Exco, Inc.
    Date Received
    June 3, 1983
    Decision Date
    January 11, 1984
    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 Exco, Inc.

    K Number Device Name
    K844203 ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
    K844175 ENTERNAL FEEDING TUBE-POLYURETHANE EF504
    K844174 FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
    K832628 VYGON THORACIC DRAINAGE-VARIOUS #'S
    K833079 CENTRACATH #130,135 & 137-HEMOCATH #
    K830910 MANOMETER SET C.V.P. #S 298/299
    K822879 ENTERAL NUTRITION 1
    K822691 VYGON EPIDURAL ANAESTHESIA TRAY
    K822836 MICROFLEX-VENOFLUX
    K822724 SUCTION TUBES
    Search all 20 clearances from Exco, Inc. →