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510(k) Data Aggregation

    K Number
    K982557
    Device Name
    BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
    Manufacturer
    BARD INTERVENTIONAL PRODUCTS DIV.
    Date Cleared
    1998-09-10

    (50 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARD INTERVENTIONAL PRODUCTS DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bard papillotomes are designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi.
    Device Description
    The Bard® ProForma™ and Apollo3™ Papillotomes are designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. A papillotome is placed under direct vision of a side-viewing duodenoscope, with or without fluoroscopic aid. Both the double lumen and triple lumen designs will have a variety of precurved tip configurations and cutting wire lengths. The Bard papillotomes are compatible with a 0.035 inch O.D. guidewire. The Bard" ProForma™ and Apollo3™ Papillotomes have equivalent intended uses as the Wiltek papillotomes. The general design characteristics and functionality are also similar. They all have a one (1) piece system construction which includes a handle, either double or triple lumen shafts, various cutting wire lengths and construction with precurved tips in multiple lengths. Both the Wiltek and Bard devices may be advanced with or without using an .035 inch guidewire through the biopsy channel of a duodenoscope with optional use of fluoroscopy. A diathermic current is applied through the cutting wire to incise the Papilla of Vater or Sphincter of Oddi. A Touhy Borst may be attached to the guidewire lumen of the double lumen device to assist in placement and minimize contrast leakage. The major design difference between the Bard and Wiltek papillotomes is the ProForma™ and Apollo³™ will have an ergonomic handle made from ABS instead of the polycarbonate handle used in the Wiltek design. The precurved tips on the Bard papillotomes will be either beveled or tapered, where the Wiltek tips are only beveled. A full range of tip lengths, from 8mm to 20mm, are provided by both manufacturers.
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    K Number
    K963484
    Device Name
    BARD HIGH FLOW PAPILLOTOME
    Manufacturer
    BARD INTERVENTIONAL PRODUCTS DIV.
    Date Cleared
    1996-11-19

    (77 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARD INTERVENTIONAL PRODUCTS DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bard High Flow papillotome is indicated for use in transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization.
    Device Description
    The High Flow papillotome dual lumen shaft is constructed out of nylon with a MDX silicone coating. The High Flow papillotome luer fitting is PVC and the handle assembly material is ABS. The High Flow papillotome electrode assembly is similar in construction to the Bard Proforma except that the set screw is stainless steel versus nickel plated brass. The High Flow papillotome shaft is an 8 french O. D. that tapers to 5.5 french tip O. D.
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