Device Dossier
Peripheral vascular guidewire
Device Dossier for Peripheral vascular guidewire (Peripheral vascular guidewire, Class IIb, sponsor Medtronic). ARTG record, intended purpose, GMDN…
- GMDN category: Peripheral vascular guidewire
Intended purpose
A long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature to function as a guide for the introduction of open-ended devices (e.g., catheters) used during procedures typically performed outside of the central circulatory system (heart) and central nervous system. The Prostream Multiple Sidehole Infusion wire is intended to be used for the selective controlled infusion of physician specified pharmacological agents or diagnostic, radiopaque contract media into the general vasculature. The Prostream is not intended for coronary or neurovascular use.