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

    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

    K Number: K952887 · Decision Aug 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    53
    Review Days
    56

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
    K Number
    K952887
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    June 23, 1995
    Decision Date
    August 18, 1995
    Product Code
    LJE
    Advisory Committee
    Unknown
    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
    LJE Catheter, Nephrostomy

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LJE), ordered by most recent decision date.

    Disposable Percutaneous Nephrostomy Dilatation Kit

    FDA 510(k)
    FDA Unclassified ·Unknown

    Introducer Needle

    FDA 510(k)
    FDA Unclassified ·Unknown

    Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

    FDA 510(k)
    FDA Unclassified ·Unknown

    In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

    FDA 510(k)
    FDA Unclassified ·Unknown

    Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

    FDA 510(k)
    FDA Unclassified ·Unknown

    Lawson Retrograde Nephrostomy Wire Puncture Set

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Meadox Medicals, Div. Boston Scientific Corp.

    K Number Device Name
    K953647 MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
    K960766 MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
    K962433 MEADOX EXXCEL EPTFE VASCULAR GRAFT
    K961847 HEMASHIELD VANTAGE (VASCULAR GRAFT
    K962342 HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
    K955460 MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
    K952884 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
    K955349 HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
    K953298 MS CLASSIQUE BALLOON DIATATION CATHETER
    K954848 HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
    Search all 53 clearances from Meadox Medicals, Div. Boston Scientific Corp. →