MicroVention Costa Rica S.R.L.

CLOSEOUT LETTER MicroVention Costa Rica S.R.L. MARCS-CMS 643188 — September 16, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Alberto Meseguer Recipient Title Vice President and General Manager MicroVention Costa Rica S.R.L. Coyol Free Zone, Building B33 Alajuela 20101 Costa Rica Alberto.Meseguer@microvention.com Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Mr. Meseguer: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 643188, dated September 30, 2022). Based on our evaluation, it appears that you have addressed the violation(s) 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/ for Bram Zuckerman, M.D. Director OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: Scafford Serron 35 Enterprise Aliso Viejo, CA 92656 Scafford.Serron@microvention.com Content current as of: 11/17/2025 Regulated Product(s) Medical Devices