Device Dossier
Safari2 Guidewire - Catheter guide wire
Device Dossier for Safari2 Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Boston Scientific).…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
The SAFARI2™ Guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.
Functional description
The SAFARI2 Guidewire consists of an 0.035 inch (≤0.92 mm)outside diameter by 275 cm working length guidewire comprised of a spring coil and core. The entire spring coil is coated with a LUBRIGREEN™ PTFE coating. The SAFARI2 Guidewire is packaged with a J-Straightener that is used to aid in the insertion of the guidewire into the delivery catheter.