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The Invisiport is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.

The predicate device and subject device are injection ports. An open ended radiopaque catheter is preattached to the predicate and subject devices. This 510(k) pre-market notification supports the addition of a catheter size variation to the predicate device. The modification to the predicate device to create the subject device is a change in the attached catheter. The predicate device attached catheter is substantially a 6 Fr catheter. The subject device attached catheter is a 4.4 Fr catheter. This change affects the attached catheter.

The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.

The Invisiport™ consists of an injection port made from material evaluated for hiocompatibility. The Invisiport has a self-sealing silicone septum. An open ended radiopaque catheter is pre-attached to the port. The silicone septum covers a reservoir that can be accessed with a non-coring Huber type needle. Power injection of contrast for imaging examinations can be performed when the port is accessed with a power-injectable Huber needle or infusion set.