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510(k) Data Aggregation

    K Number
    K964663
    Device Name
    FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
    Manufacturer
    RMDS, INC.
    Date Cleared
    1997-12-11

    (385 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    RMDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.
    Device Description
    Not Found
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    K Number
    K973216
    Device Name
    FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
    Manufacturer
    RMDS, INC.
    Date Cleared
    1997-11-25

    (90 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    RMDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.
    Device Description
    FAVC-HH: Femoral Artery Vascular Clamp-Hand Held
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    K Number
    K970027
    Device Name
    FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
    Manufacturer
    RMDS, INC.
    Date Cleared
    1997-08-08

    (217 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    RMDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Femoral Artery Vascular Clamp-Mobile is used to provide pressure hemostasis after the removal of arterial catheters following femoral catheterization procedures. The FAVC-M: Femoral Artery Vascular Clamp-Mobile is positioned prior to removal of femoral catheters and apply controlled pressure to the puncture site until hemostasis is complete.
    Device Description
    FAVC-M: Femoral Artery Vascular Clamp-Mobile
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    K Number
    K964662
    Device Name
    FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
    Manufacturer
    RMDS, INC.
    Date Cleared
    1997-02-03

    (74 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    RMDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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