Teleflex Announces FDA 510(k) Clearance and U.S. Launch of Spectre Guidewire

March 20, 2017 — Teleflex Inc. recently announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch of the Spectre Guidewire.

The Spectre Guidewire is engineered with a smooth stainless steel-to-nitinol dual-core transition that balances strength and agility. It is a 0.014-inch guidewire available in 190 cm and 300 cm lengths with a distal hydrophilic coating and a proximal PTFE coating.

Approximately 70 percent of guidewires used in percutaneous coronary interventions (PCIs) are considered workhorse wires and are used to deliver catheters, balloons, stents, and other diagnostic and therapeutic devices. As a workhorse wire, the Spectre Guidewire was designed to be applicable to the majority of PCIs, according to Teleflex.

The Spectre Guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

For more information: www.teleflex.com