BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ulrich Transfer Set

    K Number: K161723 · Decision Dec 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    24
    Review Days
    182

    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
    ulrich Transfer Set
    K Number
    K161723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ulrich GmbH & Co. KG
    Date Received
    June 22, 2016
    Decision Date
    December 21, 2016
    Product Code
    PQH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PQH Iodinated Contrast Media Transfer Tubing Set

    Similar 510(k) Clearances

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

    MEDRAD® Imaging Bulk Package Transfer Spike

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Liebel-Flarsheim IBP Transfer Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDRAD Imaging Bulk Package Transfer Spike

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDRAD® Imaging Bulk Package Transfer Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BRACCO INJEENERING TRANSFER SET

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Ulrich GmbH & Co. KG

    K Number Device Name
    K252281 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K251295 ulrichINJECT CT Motion (XD 8000)
    K241850 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K233737 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K210541 ulrichINJECT CT motion
    K202227 Artus™ cervical plate system
    K192872 ulrichINJECT CT Motion
    K192117 Small VBR™
    K171392 ulrichINJECT CT motion
    K161032 neon3™ universal OCT spinal stabilization
    Search all 24 clearances from Ulrich GmbH & Co. KG →