Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120274
    Device Name
    DELTAMAXX 18 MICROCOIL SYSTEM
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Date Cleared
    2012-03-02

    (32 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    CODMAN AND SHURTLEFF, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DELTAMAXX™ Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
    Device Description
    The DELTAMAXX " 18 Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU), and is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and 0.019 inches. The DELTAMAXX ™ 18 Microcoils are provided in Stretch Resistant (SR) or Cerecyte® models and will be offered in lengths up to 60 cm and diameters ranging from 3 mm to 24 mm. The DELTAMAXX™ 18 Microcoils are fabricated from the same platinum alloy wire used in the DELTAPAQ® Microcoils. The wire is wound into a primary coil (containing either a polypropylene (SR) or absorbable polymer suture (Cerecyte®) inside the wind and then formed into a secondary helical coil shape. The Microcoil is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The coil is the implantable segment of the device, and is detached from the device positioning unit by the Micrus Detachment Control System.
    Ask a Question

    Page 1 of 1