Our proven track record for delivering exceptional Nitinol components, balloon components, and balloon catheters demonstrates our commitment to superior quality and consistency in all that we do. We pride ourselves on delivering material science technologies and development services that meet the most stringent requirements to ensure every customer’s standards and deadlines are met every time. Key elements of our commitment to quality include:

Quality
  • ISO 13485: Certified
  • FDA Registered and compliant with the Quality System Regulation
  • ISO 14971:2007 Risk Management
  • Class I, II, and III devices, including Premarket Approval (PMA) products
  • ISO 8 Certified Cleanroom Controlled Environments

Quality Documents

To request a copy of our ISO 13485 Certificate or Quality Manual, please contact our QA department


HIGH QUALITY MEDICAL DEVICES COME FROM HIGH QUALITY RAW MATERIALS

NITINOL MATERIAL SOURCING

As the highest-volume supplier of Nitinol materials for the medical device industry, Confluent Medical Technologies has maintained its position as the premier vendor for all Nitinol sourcing. Count on us to deliver:

  • Medical-grade Nitinol alloys that are among the purest available, with the lowest carbon content in the industry
  • Materials produced with some of the highest tolerances obtainable
  • A range of superelastic and shape memory alloys that conform to all ASTM standards.

CUSTOM MEDICAL EXTRUSION

Our extrusion capabilities include highly sophisticated equipment along with a comprehensive inventory of pin and die sets that allow us to give customers a complete range of complex medical tubing, including:

  • Balloon tubing
  • Single lumen tubing
  • Multi-lumen tubing
  • Striping co-extrusion
  • Tri-layer
  • Bump tubing
  • Lead tubing
  • Custom welding sleeves

Get more information on material sourcing and custom medical extrusion.