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# 2 Final Coronary Guidances Out
- URL: https://www.fdaweb.com/2-final-coronary-guidances-out/
- Published: 2019-10-09T12:00:00.000Z
- Updated: 2026-09-15T01:55:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145200

FDA has issued a guidance, *Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations*, to provide recommendations for information to be included in the device labeling as submitted in PMAs or 510(k)s for Class 2 and 3 devices. The [document](https://www.fda.gov/media/113951/download?ref=fdaweb.com) is intended to enhance the consistency of coating-related information across the product areas, as well as to promote safe use of the devices in the clinical setting, the agency says.

A second guidance, *Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling*, includes recommendations for 510(k) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature. The [document](https://www.fda.gov/media/113959/download?ref=fdaweb.com) says the recommendations reflect current practices and are intended to promote consistency and to facilitate efficient review of the submissions.