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

    TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)

    K Number: K936282 · Decision Jul 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    37
    Review Days
    200

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    Basic Information

    Device Name
    TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
    K Number
    K936282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Neurovascular, Inc.
    Date Received
    December 30, 1993
    Decision Date
    July 18, 1994
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Cordis Neurovascular, Inc.

    K Number Device Name
    K082324 TRUFILL DCS SYRINGE
    K080967 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
    K071962 VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
    K070279 MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
    K063254 THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
    K053197 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
    K043538 HYPERTRANSIT INFUSION CATHETER
    K032553 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
    K030963 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
    K021591 PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
    Search all 37 clearances from Cordis Neurovascular, Inc. →