Coronary guidewires are pre-amendment class II devices (21 CFR 870.1330) and can only be marketed after receiving a substantial equivalence determination from FDA on a premarket notification (510(k)) submission. (Cerebrovascular guidewires were not specifically classified; therefore, cerebrovascular guidewires are based upon the coronary guidewire classification.) This document is intended to outline the types of scientific data considered necessary for submission in an investigational device exemptions (IDE) application, when applicable, and in a 5lO(k) application.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.