Intravenous Catheter Receives 510(k) Clearance


May 8, 2008

May 7, 2008 - The FDA has cleared for marketing a new safety engineered short-term peripheral intravenous (IV) catheter, the VantageCath, which is designed to reduce exposure to bloodborne pathogens during the placement of the catheter and also provide the clinician with desirable feature sets.

Existing safety engineered peripheral IVs have mechanisms to protect the needle that has been contaminated, but do not usually address the problem of blood leaking out of an open hub. The VantageCath by Advantage Medical Devices utilizes a closed-hub system that reportedly eliminates the need to tamponade above the site while connecting tubing or saline lock.

The VantageCath comes with built in, needle-free access to empower the clinician with primary needle stick injury prevention and can immediately be used to deliver push meds, connect to an extension tubing or standard IV or pump tubing. The VantageCath utilizes a push button retraction mechanism for shielding the used needle that is similar to existing devices to minimize the learning curve for clinicians and has been well received by nurses, paramedics, and physicians who used the device during the Simulated Clinical Use study.

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