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TechDevice Corp.

650 Pleasant St.
Watertown, MA 02472
Tel: 617/972-5802
Fax: 617/972-5812

Web: http://www.techdevice.com
E-mail: brownm@techdevice.com


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GUIDEWIRES, BALLOONS and BALLOON CATHETERS

TechDevice specializes in the design, development and contract manufacturing/assembly of a broad range of guidewires, balloons and balloon catheter assemblies. This includes 510(k) approved products for OEM's that prefer total outsourcing solutions. TechDevice offers superior quality systems, competitive pricing and the resources necessary to execute jobs in a timely fashion - from front end new product development through contract manufacturing to back-end value-added services.

Quality & Regulatory

Certifications

  • ISO 13485:2003 and CMDCS Certification
  • FDA Registered
  • Design control system compliant with FDA & European regulations
  • Experience with the FDA 510(k) approval process

    Guidewires – Finished 510(k) Approvals and Customized to Specifications

    TechDevice has completed all of the front end work - design, prototyping and 510(k) submissions with approvals for OEM's who prefer total outsourcing solutions. Click here to view a matrix of TechDevice's 510(k) approved guidewire portfolio.

    TechDevice provides quality custom contract manufacturing to exact specifications of pre-approved guidewires. This includes any shape or size, using all available materials.

    Balloons – Customized to Specifications

    TechDevice specializes in the development and contract manufacturing of a wide range of high-quality medical balloons. TechDevice balloons are special as a result of the exceptional quality and consistency of the materials used as well as the skill exhibited by our technicians who carefully produce each and every balloon to exact specifications.

    Materials include: Yulex® all-natural latex, Hevea latex, compliant, semi-compliant and non-compliant types.

    Balloon Catheters - Finished 510(k) Approvals and Customized to Specifications

    TechDevice offers a full range of finished 510(k) approved balloon catheters. Currently, TechDevice has FDA approval for latex occlusion balloons for temporary intravascular occlusion. Also, TechDevice custom manufactures and assembles a wide variety of balloon catheters as detailed below:

    Types: Radiopaque, hydrostatic, pneumatic
    Materials/Balloons: Refer to materials balloons above
    Materials/Catheter Shafts: Any kind of material
    Sizes: Balloons any size; catheter shafts 5 French-14 French

    Capabilities

  • New product development
  • 510(k) submission process
  • Manufacturing guidewires
        Centerless grinding
        End forming
        Coil winding
        Cross winding
        Spot welding
        Brazing
        Ball Welding
        Coatings
        Swaging
        Ultrasonic cleaning
  • Manufacturing balloons
        Solid state balloon dipping equipment/ovens for latex applications
        Class 100,000 Hepa filtered environment
  • Manufacturing balloon catheters
        Radiopaque marker swaging
        Advanced balloon attach process
        Pad printing
  • Packaging, labeling, sterilization
  • Supply chain management

    Categories this company is listed under in the North American Suppliers Directory:

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