Device Dossier
RotaWire Guide Wire - Catheter guide wire
Device Dossier for RotaWire Guide Wire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Boston Scientific).…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
Indicated for use with the Rotablator Rotational Angioplasty System. The guidewire is used to deliver rotational atherectomy devices to the target lesion as well as setting the cutting vector when the burr is advanced.
Functional description
The RotaWire Guide Wire is a single-use guide wire that acts as a guide rail for the Rotablator Rotalink Exchangeable Catheter. It is made from stainless steel with a distal spring tip which acts to retain the burr from passing distally off the wire. It is 325cm in length with a maximum diameter of 0.014". It is also available in two tip lengths