BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NAVARRE UNIVERSAL DRAINAGE CATHETER

    K Number: K951475 · Decision Apr 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    9
    Review Days
    25

    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
    NAVARRE UNIVERSAL DRAINAGE CATHETER
    K Number
    K951475
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navarre Biomedical , Ltd.
    Date Received
    March 30, 1995
    Decision Date
    April 24, 1995
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBX Catheter, Irrigation

    Similar 510(k) Clearances

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

    MOERAE VEIN PREPARATION KIT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GRAFTGUARD PRESSURE CONTROLLING SYRINGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEUTSCH ANTI-BLOCKAGE WOUND DRAIN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GRAFTSAVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MISONIX IRRIGATION SYSTEM MOEDL BC20P

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Navarre Biomedical , Ltd.

    K Number Device Name
    K955110 NAVARRE PERCUTANEOUS BILIARY DRAINAGE
    K955505 OPTI-DRAIN MULTI-USE DRAINAGE CATHETER
    K945909 NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER
    K951907 NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER
    K943663 NAVARRE 600 ML DRAINAGE BAG
    K942315 NAVARRE PERCUTANEOUS ACCESS SET
    K933600 NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
    K932391 NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET