Device Dossier
ROTAWIRE™ Drive Guidewire - Catheter guide wire
Device Dossier for ROTAWIRE™ Drive Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Boston…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
These guidewires are intended for use with the Rotablator or ROTAPRO Rotational Atherectomy System
Functional description
These guidewires are all 0.009 in (0.23 mm) in diameter with an enlarged distal spring tip of 0.014 in (0.36 mm) diameter.The spring tip configuration is atraumatic, radiopaque, and can be shaped to form a steerable system. The wire shaft is constructed of stainless steel with a smooth finish. These guidewires, designed exclusively for the Rotablator and ROTAPRO Systems, can be independently advanced and steered.