BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA

    K Number: K844433 · Decision Mar 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    64
    Applicant Total
    19
    Review Days
    117

    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
    VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
    K Number
    K844433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vas-Cath of Canada , Ltd.
    Date Received
    November 16, 1984
    Decision Date
    March 13, 1985
    Product Code
    LFJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFJ Catheter, Subclavian

    Similar 510(k) Clearances

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

    MEDSURG INSERTION TRAY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AKCESS0CATH KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AKCESS-CATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SPLITTABLE SHEATH INTRODUCER SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COAXIAL ACUTE CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Vas-Cath of Canada , Ltd.

    K Number Device Name
    K875188 LUER LOCK CONNECTORS / RIDIG P.V.C.
    K871817 VAS-CATH PERITONEAL DIALYSIS CATHETER
    K871488 VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH
    K871487 VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH
    K863982 VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
    K853283 VACCESS TM 4006
    K844854 OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT
    K844800 OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
    K850009 EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
    K844336 VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH
    Search all 19 clearances from Vas-Cath of Canada , Ltd. →