Search Results

The SCIMED ChoICE™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catherers or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE™ Guide Wire family is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and two tip configurations, straight shapeable and pre-formed J-Tip. The four tip flexibilities available will be Floppy, Intermediate, Standard, and Extra Support. A polymer sleeve, extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE™ Hydrophilic Coating. The available lengths for the guide wires will be ChoICE-190 cm, ChoICE Plus-182 cm and ChoICE Exchange-300 centimeters.

This document does not contain the information required to populate the fields of the request. The provided text describes the technical characteristics and non-clinical test summary for PTCA Guide Wires, focusing on material and manufacturing changes. It mentions general "design requirements" and "in vitro testing and evaluation" but does not provide specific acceptance criteria values, device performance metrics, details about a study with a test set, ground truth, or expert involvement. It also does not involve AI or MRMC studies.

Ask a specific question about this device