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www.fdanews.com/articles/72331-fda-clears-shpi-s-miniloc-safety-infusion-set

FDA Clears SHPI's MiniLoc Safety Infusion Set

May 16, 2005

Specialized Health Products International (SHPI), a company specializing in the design and development of medical safety devices, has received 510(k) clearance from the FDA to market its next generation safety Huber needle, MiniLoc Safety Infusion Set.

The MiniLoc Safety Infusion Set is SHPI's second entry into the growing safety Huber needle market -- the first being its LiftLoc Safety Infusion Set. MiniLoc's small footprint, needle forward design and enhanced angled tubing make the product easy to dress, facilitate placement in dual lumen ports, and provide excellent site visibility. The product's design enables controlled, easy engagement of the safety mechanism. MiniLoc has a smooth comfortable base that is designed for patient comfort, as well as specially lubricated needles that significantly reduce needle penetration force.

Huber needles are used to access surgically implanted, subcutaneous ports for vascular access on a repeated basis over an extended period of time. As such, they are hollow-bore and potentially blood-filled at the time of removal, with a significant need for an effective safety solution. A primary use of Huber needles is the infusion of chemotherapeutic agents for cancer patients.