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

    THORACIC CATHETERS

    K Number: K883474 · Decision Sep 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    28
    Review Days
    28

    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
    THORACIC CATHETERS
    K Number
    K883474
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Westmark, Sterile Packing Systems, Inc. (Sps)
    Date Received
    August 16, 1988
    Decision Date
    September 13, 1988
    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 Westmark, Sterile Packing Systems, Inc. (Sps)

    K Number Device Name
    K896800 IRRIGATION TRAY
    K896799 PARACERVICAL/PUDENDAL TRAYS
    K896559 INFANT FEEDING TUBE
    K896794 SPECIMEN CONTAINER
    K896806 CATHETER PLUG/PROTECTOR
    K896798 TRACHEOSTOMY TRAY
    K896797 SUCTION CATHETER KIT
    K896215 MERCY HIP/KNEE PACK
    K896804 MANIFOLD
    K896556 UNIVERSAL POOLE SUCTION TUBE
    Search all 28 clearances from Westmark, Sterile Packing Systems, Inc. (Sps) →