FDA Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling
标准简介
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling[附网盘链接]由FDA于不久前发布，适用于US。标准截图
![Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling[附网盘链接]](/img/20210914103634bwg6g.jpg)
标准文档说明
标准文档类型为Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Coronary, Peripheral, and Neurovascular Guidewires -
Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction This guidance document provides recommendations for premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. For the purposes of this guidance, the coronary vasculature includes blood vessels within the heart, including the ostium of the left main coronary artery; the neurovasculature includes blood vessels within the cranium, typically considered the vasculature distal to the cervical segment of the internal carotid artery; the peripheral vasculature includes all other cardiovascular vasculature. This document is intended to assist industry in designing and executing appropriate performance testing to support a 510(k) submission and provides recommendations for content and labeling to include in the submission. For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database web site at https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfStandards/search.cfm. For more information regarding use of consensus standards in regulatory submissions, please refer to FDA guidance titled “Appropriate Use of 1
Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
1
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices
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