Device Dossier
ACUITY Venous Guidewires - Catheter guide wire
Device Dossier for ACUITY Venous Guidewires - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Boston…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
ACUITY Venous Guidewires are intended to facilitate the placement of Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature.
Functional description
The ACUITY guidewires are constructed using a 304V stainless steel core wire with the distal portion tapered in diameter to provide added flexibility. The distal end of the wire is radiopaque, and the distal ribbon is shapeable to facilitate steering into the selected vein. The guidewires are designed to be compatible with 0.014" Left Ventricular Leads. They are hydrophilic coated steerable guidewires in which the distal tip is shapeable and has a radiopaque tip.