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GUIDANCE DOCUMENT

Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff June 2018

Draft

Not for implementation. Contains non-binding recommendations.

Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling

Docket Number:
FDA-2018-D-1775
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides draft recommendations for 510(k) submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft document is intended to assist industry in designing and executing appropriate performance testing to support a premarket notification and provides recommendations for content and labeling to include in the submission. When final, this guidance will replace the “Coronary and Cerebrovascular Guidewire Guidance” document dated January 1995. This draft guidance is issued for comment purposes only.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1775.