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

    FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)

    K Number: K973216 · Decision Nov 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
    K Number
    K973216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rmds, Inc.
    Date Received
    August 27, 1997
    Decision Date
    November 25, 1997
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by Rmds, Inc.

    K Number Device Name
    K964663 FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
    K970027 FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
    K964662 FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15