Search Results

The Primero Safe Access System is intended to facilitate placing a catheter through the skin into a vein or artery. The introducer needle is used in facilitating entry through the skin into a vein or artery to provide a conduit for the guidewire. The guidewire is an accessory device which is used for placement of a catheter or sheath in the vein or artery.

The Primero Safe Access System (SAS) is a catheter introducer that facilitates a quick approach for placement of a guidewire during the introduction of a catheter for vascular access. The Primero SAS combines an introducer needle, guidewire, advancer, and storage tube into a single integrated device to promote ease of use and quick access by the healthcare provider. The introducer needle consists of an 18Ga stainless steel needle with an echogenic tip and terminates on the proximal end with a colored translucent standard female luer lock hub. The introducer needle has an enhanced echogenic tip, that has been slightly modified to incorporate a small bulb-like feature at the proximal end of the tip bevel to enhance ultrasonic visualization during vascular access. The introducer needle is secured to the advancer through a luer lock connector at the distal end of the advancer. The advancer is a light-weight polymer handpiece that allows the user to grip the entire setup while introducing the needle into the vessel and then advancing the guidewire through the needle by either 'thumb" or 'two-finger" advancing based on the preference of the user. A cutout in the advancer handpiece wire path exposes the guidewire and conveniently allows the user to advance the guidewire with their fingers without having to let go of the handpiece. An internal path within the handpiece feeds the guidewire from a storage tube into the introducer needle. The looped storage tube is connected to the proximal end of the advancer and holds a spooled pre-loaded guidewire ready for deployment. A back stop has been inserted into the tube at the proximal end to prevent a guidewire from being over-retracted from the advancer. The Primero SAS is pre-loaded with a commercially available guidewire (previously cleared under K142393) ready for deployment through the introducer needle once placed in the target vessel. The guidewire is comprised of an uncoated nitinol core wire that is tapered at the distal tip where a stainless-steel coil is secured over the full-length of the core. The South53 Primero Safe Access System (SAS) integrates all the necessary elements into a single device to complete the Seldinger technique as part of a vascular access procedure.

The Primero SAS is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used.

N/A

Ask a specific question about this device