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Coronary and Cerebrovascular Guidewire Guidance January 1995

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.