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510(k) Data Aggregation

    K Number
    K181904
    Device Name
    5 FR Dual Lumen Piper PICC
    Manufacturer
    Date Cleared
    2018-09-25

    (71 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    Piper Access LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 5 FR DL Piper PICC Catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and prolonged exposure to intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5mL/sec for power injection of contrast media.
    Device Description
    The 5 French (FR) Dual Lumen (DL) Piper PICC is a single use peripherally inserted central catheter made from a specially-formulated medical grade polyurethane material. The Piper PICC is designed to perform infusion, intravenous therapy, blood sampling and power injection of contrast media, and is compatible with intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5 mL/sec. The Piper PICC is a 5 French catheter with two 18-gauge lumens and will be provided with 55cm of effective length. The catheter has a reverse-tapered design. The catheter is inserted peripherally by the clinician and is trimmable to fit different patient sizes. It is inserted with a Seldinger or modified-Seldinger technique with compatibility to guidewires up to 0.019" in outer diameter. The catheter distal tip is positioned in the lower 1/3 of the Superior Vena Cava (SVC). The effective length of the catheter including the distal end is radiopaque, which allows for catheter tip visualization. The Piper PICC catheter includes an extruded polyurethane catheter shaft molded to an injection molded polyurethane hub with extruded extension legs molded to luer-lock fittings, which provide attachments for IV administration. The junction has suture wings to allow for securement to the patient. Clamps are attached to both extension legs on the catheter. The distal end of the catheter shaft is a dual lumen symmetrical D-shape design that does not differ in material from the remainder of the shaft. With the exception of the reverse-tapered section of the shaft, the distal end is also dimensionally identical to the remainder of the shaft. The proximal end of the catheter consists of two power injectable extension legs, which each have a luer lock style connection depicting gage size, thumb clamp, ID tag. The catheter has an average priming volume is 0.61 mL The Piper PICC is packaged in a catheter only kit and provided sterile to the end user. There are no additional components in the kit.
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