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

    SOFTRAC-PTA PERIPHERAL DILATATION CATHETER

    K Number: K882826 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    9
    Review Days
    200

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    Basic Information

    Device Name
    SOFTRAC-PTA PERIPHERAL DILATATION CATHETER
    K Number
    K882826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Schneider-Shilley (Usa)
    Date Received
    July 8, 1988
    Decision Date
    January 24, 1989
    Product Code
    LIT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Schneider-Shilley (Usa)

    K Number Device Name
    K875175 MODIFIED PERIPHERAL DILATATION CATHETERS
    K881197 SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER
    K875322 MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER
    K875323 MODIFIED SCHNEIDER-SHILEY WIRE TORQUER
    K875324 MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES
    K875327 MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
    K875325 MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK
    K875326 MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER