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The catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

The Versa-Cath Arterial Catheter is a dual lumen nylon tube with a natural latex balloon attached to a distal end. There are two stopcocks affixed to the proximal end, one for balloon inflation and the other for fluid irrigation and/or aspiration. It will be packaged with a syringe and a stylet. The syringe is a pre-amendment device and the stylet is marketed under 510(k) K832023. The catheter will be available in 5 sizes and 3 lengths.

to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling.

The Ideas' Dual Port is a totally implantable system designed to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling. Port access is performed by percutaneous needle insertion using a "Huber type" non-coring needle. The system includes an injection portal with self sealing septum, compression lock and Tecoflex® catheter.

The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

The Vaso-Safe Arterial Embolectomy Catheter is a single lumen nylon tube with a natural latex balloon attached to a distal end and a stopcock affixed to the proximal end. It will be packaged with a syringe. The catheter will be available in 5 french sizes and 3 lengths.

The intended use of these devices is to provide a temporary bypass during carotid endarterectomy.

The Pruitt-Inahara Carotid Shunt (Model 400-40-8F) and the Inahara-Pruitt Carotid Shunt (Model 500-50-8F) are dual lumen balloon shunts which channel and divert blood in the carotid artery during endarterectomy. The 8 French shunts are for use in arteries too small to accommodate a 9 French shunt. Both the 400-40-8F and 500-50-8F have a T Port to confirm patency and allow back-bleeding after insertion. There is an external safety balloon on the inflation port for the balloon which lies in the internal carotid artery. The safety balloon is designed to inflate when the internal carotid balloon reaches 17 psi; this reduces the possibility of balloon overinflation and resultant vessel damage. All the materials are identical to those used in other models of Ideas for Medicine's shunts. These materials have been used for years and were certified to meet the requirements of the USP Class VI testing for biocompatibiltiy. Every lot is supplied sterile and non-pvrogenic.

The intended use of this device is for occlusion of the internal carotid artery during endarterectorny.

The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. Every lot is supplied sterile and nonpyrogenic.

The Pruitt Biliary Catheters are intended for use in the removal of stones, ductal debris and the exploration of the biliary tube.

The Pruitt biliary catheter is a radiopaque multi lumen, balloon catheter. The ancillary lumen(s) are for injection and/or irrigation: another lumen inflates the balloon. All materials have been used by Ideas for Medicine, Inc. in cardiovascular catheters and/or laparoscopic instruments with no report of adverse events. All materials have been subject to testing per the Biocompatibility testing.