Device Dossier

Merit MAK Mini Access Kit - Catheter guide wire

Device Dossier for Merit MAK Mini Access Kit - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class IIa, sponsor Merit Medical).…

Intended purpose

Guide wires to be inserted intravascularly, for subsequent catheter placement.

Functional description

The Merit Mak (Mini Access Kit) provides access to the vascular system using a 0.018" (0.46mm)guide wire, 21 gauge needle with either a 4Fr or 5Fr dilator/ introducer.

TGA Public Summary