FDA 510(k) Applications Submitted by Nikita Basandra

FDA 510(k) Number Submission Date Device Name Applicant
K220109 01/13/2022 DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System Cardiovascular Systems Inc.
K173527 11/14/2017 Digitex Delivery Device Coloplast A/S


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact