FDA Issues 510(k) Recommendations for Coronary, Peripheral and Neurovascular Guidewires

The FDA released draft guidance with recommendations for 510(k) submissions of guidewires intended for use in coronary, peripheral and neurovasculature procedures, including recommendations for biocompatibility tests.

The guidance provides an example table with suggested information to include in a side-by-side comparison with a similar legally marketed predicate device, such as tip material, shelf life, indications for use, device length, wire diameter and wire material.

Because guidewires contain materials that come in contact with patients and could produce a harmful effect, the FDA recommends that all patient-contacting materials in the device undergo a biocompatibility determination.