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

    MEHIGAN-PILLING PHLEBETOME TM

    K Number: K911100 · Decision Jun 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    39
    Review Days
    101

    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
    MEHIGAN-PILLING PHLEBETOME TM
    K Number
    K911100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pilling Co.
    Date Received
    March 12, 1991
    Decision Date
    June 21, 1991
    Product Code
    MGZ
    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
    MGZ Valvulotome

    Similar 510(k) Clearances

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

    LimFlow Vector

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LimFlow Vector

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EZE SIT Valvulotome

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Antegrade LeMills Valvulotome

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME

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

    Other Clearances by Pilling Co.

    K Number Device Name
    K934427 PILLING LAPAROSCOPIC INSTRUMENTATION
    K925370 TRIANGULAR JAW MICROLARYNGEAL FORCEPS
    K925198 KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR
    K922971 NO-SCALPEL VASCETOMY INSTRUMENTS
    K914015 CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP
    K911099 MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
    K904507 PILLING BRUSH VALVULOTOME
    K884946 JEHLE CORONARY PERFUSION CATHETERS
    K882930 LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX
    K874242 JEHLE CORONARY PERFUSION CATHETERS
    Search all 39 clearances from Pilling Co. →