FDA 510(k) Applications Submitted by Kris Miller

FDA 510(k) Number Submission Date Device Name Applicant
K110085 01/11/2011 VANTAGE VIEW SYSTEM ST. JUDE MEDICAL
K210586 02/26/2021 Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system Cardiovascular Systems Inc.
K220568 02/28/2022 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Cardiovascualr Systems Inc.
K150583 03/09/2015 Aequalis PerFORM+ Shoulder System TORNIER, INC.
K190634 03/12/2019 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System Cardiovascular Systems Inc.
K101697 06/16/2010 ENSITE VERISMO SEGMENTATION TOOL V.2.0 ST. JUDE MEDICAL
K132073 07/03/2013 EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE ST. JUDE MEDICAL
K182397 09/04/2018 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Cardiovascular Systems Inc.


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