Device Dossier

Synchro Guidewire - Catheter guide wire

Device Dossier for Synchro Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Stryker). ARTG record,…

Intended purpose

The guidewire is intended to be used for neurovasculature use. It can also be used to selectively introduce and position catheters and other interventional devices within the neurovasculature.

Functional description

Synchro is a steerable guidewire with a shapeable distal tip. The Guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy neurovascular disease. The proximal portion is coated with polytetrafluoroethylene (PFTE) and the distal portion of the guidewire is radiopaque and coated with hydrophilic polymers. It also includes a torque device and an introducer.

TGA Public Summary