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510(k) Data Aggregation

    K Number
    K983830
    Device Name
    COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
    Manufacturer
    MALLINCKROOT, INC.
    Date Cleared
    1999-04-16

    (168 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKROOT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.
    Device Description
    The Mallinckrodt PTA Catheter is intended for single patient use and is disposable, sterile and non-pyrogenic. This dilatation catheter is a coaxial double lumen catheter with a balloon mounted near the distal tip. The balloon is designed to inflate to a known diameter and length at pressures stated on the label (nominal inflation). The outer lumen is used for inflation of the balloon while the inner lumen permits (1) the use of a guide wire to facilitate catheter advancement to and through the stenosis to be dilated, and (2) low flow administration of contrast media to aid in correct positioning of the balloon. The lumens bifurcate from the catheter shaft to two molded hubs (proximal end of catheter), one for the inflation lumen and one for the guide wire lumen. The hubs are labeled for easy identification. The bifurcation is supported by a strain relief sleeve at the catheter end. Two radiopaque markers, within the balloon segment of the catheter, delineate the working length of the balloon for proper balloon orientation within a stenosis. The catheter tip is a highly radiopaque, soft, atraumatic material. The Mallinckrodt PTA Catheter is available in two shaft diameters (4 and 5 Fr) and several shaft lengths (4 Fr - 90, 135 cm and S Fr - 45, 75, 125 cm). The catheter has a range of balloon sizes from 3 mm to 12 mm in inflated diameter and from 2 to 10 cm in length. (Note: Neither the 4 nor 5 Fr catheter with 12 min balloon is available in 8 and 10 cm length.) The catheters will be available with or without a hydrophilic coating.
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