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The MedAmicus FlowGuard Peelable Introducer in indicated for indications i or ooc. This modifines pacing leads or catheters in the venous system.

The McdAmicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard 100 Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The FlowGuard™ Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The MedAmicus FlowGuard" Peelable Introducer is packaged in three configurations: 1) a convenience kit containing a MedAmicus FlowGuard11M Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. 2) individually pouched, sterile MedAmicus FlowGuard™ Peelable Introducer and 3) bulk, nonsterile MedAmicus FlowGuard™ Peclable Introducers.

The MedAmicus FlowGuard™ Peelable Introducer indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The MedAnicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard™ Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The FlowGuard™ Peelable Introducer has a "teat-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The MedAmicus FlowGuard™ Peelable Introducer is packaged in three configurations: 1) a convenience kit containing a MedAmicus FlowGuard 100 Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. 2) individually pouched, sterile MedAmicus FlowGuard™ Peelable Introducer and 3) bulk, nonsterile MedAmicus FlowGuard™ Peelable Introducers.

The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.

The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.

The MedAmicus Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The MedAmicus Valved Peelable Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. Percutaneous introducers are small diameter tubular shaped devices with integrated proximal handles. The Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The Valved Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The Valved Peelable Introducer includes a sliding valve. When the valve is slid over the proximal end of the sheath, a device may be passed through the valve into the sheath, providing for reduced blood loss and reduced risk of air intake. The valve may be slid so that it is not covering the opening to the inner diameter of the sheath as well. The valve is constructed of a piece of silicon which snaps into a valve 'body' constructed of molded components.

The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.

The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads.

The Percutaneous Introducer Set is a single use device allowing for introduction, manipulation, and removal of stimulation leads after percutaneous entry is gained with a needle. The sheath is made of HDPE (High Density Polyethylene) with a HDPE hub. It is slightly tapered at the distal end to make a smooth transition to the dilator. The dilator is made of 304 stainless steel tubing tapered at the distal end for smooth insertion. It has a molded HDPE hub. The guidewire directional guide is made of 304 stainless steel wire with radiuses at each end. It has depth markings etched into the surface along the distal end.

For percutaneous introduction, manipulation, and removal of epidural stimulation leads.

The MedAmicus Epidural Introducer is intended to be used in the same manner as the ANS (Neuromed) Introde INT-8 cleared by the FDA under K930242 and in a similar manner to the Coaxial Dilator manufactured by MedAmicus, Inc. and cleared by the FDA under K990705.

The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

The proposed coaxial introducer set consists of an inner dilator within a slightly shorter outer sheath. The inner dilator is high density polyethylene and has length of approximately 4.5 inches. The outer sheath is also high density polyethylene and is approximately 3.5 inches long. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub on the inner dilator is high density polyethylene. The hub on the outer sheath is also high density polyethylene. The set may be 4F, 4.5F or 5F. The kit contains a 21 gauge disposable aspiration and injection needle, a .018 inch diameter guidewire, and a Coaxial Introducer Set consisting of a sheath and dilator.