OBTURATOR 7510SET HK II MITRAL 26L CE


Product Overview

OBTURATOR 7510SET HK II MITRAL 26L CE
Hancock™ II - 7510SET


Device Description

A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • The mitral obturators include the following sizes: 25 mm, 27 mm, 29 mm, 31 mm, and 33 mm.
    • The mitral obturators include the following sizes: 25 mm, 27 mm, 29 mm, 31 mm, and 33 mm.


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: DTI

    Device Name: Sizer, Heart-Valve, Prosthesis

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.3945

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00763000318420

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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