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

    ACS HI-TORQUE IRON MAN GUIDE WIRE

    K Number: K963702 · Decision Jan 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    103
    Review Days
    128

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    Basic Information

    Device Name
    ACS HI-TORQUE IRON MAN GUIDE WIRE
    K Number
    K963702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Cardiovascular Systems, Inc.
    Date Received
    September 16, 1996
    Decision Date
    January 22, 1997
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Advanced Cardiovascular Systems, Inc.

    K Number Device Name
    K012534 HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
    K000550 OTW MEGALINK SDS BILIARY STENT SYSTEM
    K994229 VERIPATH PERIPHERAL GUIDING CATHETER
    K992169 ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
    K990867 RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
    K962495 INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
    K961471 INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
    K955175 ACS ANCHOR EXCHANGE DEVICE
    K953987 ACS TOURGIDE GUIDING CATHETER
    K952205 ACS POWERBASE GUILDING CATHETER
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