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

    DA-46 FLUID BARRIER

    K Number: K891752 · Decision Apr 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    36
    Review Days
    15

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    Basic Information

    Device Name
    DA-46 FLUID BARRIER
    K Number
    K891752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Akcess Medical Products, Inc.
    Date Received
    March 23, 1989
    Decision Date
    April 7, 1989
    Product Code
    FIB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIB Protector, Transducer, Dialysis

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    Other Clearances by Akcess Medical Products, Inc.

    K Number Device Name
    K926374 SILICONE CATHETER REPAIR KITS
    K925819 AKCESS0CATH KIT
    K925818 AKCESS-CATH
    K930630 RIGHT ATRIAL CATHETER
    K920634 SPLITTABLE SHEATH INTRODUCER SET
    K931120 COAXIAL ACUTE CATHETER
    K914936 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
    K920331 RIGHT ATRIAL CATHETER KITS
    K914826 AKCESS-CATH KIT
    K915215 CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
    Search all 36 clearances from Akcess Medical Products, Inc. →