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

    URESIL VALVE CUTTER

    K Number: K905528 · Decision Apr 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    45
    Review Days
    129

    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
    URESIL VALVE CUTTER
    K Number
    K905528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Uresil Corp.
    Date Received
    December 10, 1990
    Decision Date
    April 18, 1991
    Product Code
    DWQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWQ Stripper, Vein, External

    Similar 510(k) Clearances

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

    PhasTIPP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRIVEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PILLING BRUSH VALVULOTOME

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSITUCAT VALVE STRIPPER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HALL VEIN STRIPPER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Uresil Corp.

    K Number Device Name
    K003753 GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
    K980278 URESIL VASCU-FLO INFUSION CATHETER
    K981344 URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
    K980282 URESIL DILATOR WITH RADIOPAQUE MARKER
    K980889 URESIL NEPHRO-URETERAL STENT
    K972582 URESIL GUIDEWIRE
    K972583 URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
    K953923 URESIL INTRODUCING NEEDLE
    K945934 URESIL(R) GUIDEWIRE
    K942688 NEPHRO-URETERAL STENT
    Search all 45 clearances from Uresil Corp. →