Peripheral vascular atherectomy devices : premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff Guidance for industry United States. Department of Health and Human Services United States. Food and Drug Administration Atherectomy -- instrumentation Device Approval Equipment Safety This guidance document provides recommendations for 510(k) submissions for peripheral vascular atherectomy devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular atherectomy submissions. For the current edition of the FDA-recognized consensus 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, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff.” [Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021 United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Technical Report Text 1 online resource (1 PDF file (29 pages)). nlm:nlmuid-9918350982806676-pdf 9918350982806676 http://resource.nlm.nih.gov/9918350982806676 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0