US Vascular LLC

CLOSEOUT LETTER US Vascular LLC MARCS-CMS 554761 — March 18, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. Galen T. Spooner Recipient Title Owner US Vascular LLC PO Box 199 Beaverton , OR 97075 United States mailto:gus@vasculab.com Issuing Office: Office of Medical Device and Radiological Health Division 3/West United States Dear Mr. Spooner: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL CMS 554761 dated June 7, 2018]. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Jessica Mu Director of Compliance Branch Office of Medical Device and Radiological Health Division 3/West Content current as of: 03/20/2020 Regulated Product(s) Medical Devices